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Myco Medical Supplies Inc - Technocut Plus,Sterile Single Use Safety Scalpel. - Class 2 Recall
Technocut Plus,Sterile Single Use Safety Scalpel, Distributed by: Myco Medial Cary, NC 27513. The Technocut Plus Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology, and minor medical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Advantage Workstation - Class 2 Recall
Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(version6.0 to version6.11) and only when one or both of these applications is installed: " CardIQ Xpress Pro or Plus " CardEP Advantage Workstations AW Volume Share 2 (AW version 4.4). ONLY IF ONE OF FOLL...
Source: Medical Device Recalls - December 19, 2012 Category: Medical Equipment Source Type: alerts

Leica Microsystems, Inc. - Novocastra ReadytoUse Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase - Class 2 Recall
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. RTU-TdT-339 is intended for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections. The clinical interpretation of any staining o...
Source: Medical Device Recalls - December 13, 2012 Category: Medical Equipment Source Type: alerts

Medical Information Technology, Inc. - MEDITECH Anatomical Pathology Software - Class 2 Recall
MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13 Product Usage: Meditech Anatomical Pathology Software records, stores, codes, searches and provides reports for pathology cases. It enables pathology staff and other personnel to access related findings in real time. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2012 Category: Medical Equipment Source Type: alerts

Cell Marque Corporation - Cell Marque CD7 (MRQ12); - Class 2 Recall
Cell Marque CD7 (MRQ-12); Mouse Monoclonal Antibody, Antibody is bottle in HDPE bottle with screw cap lid with container label. Then put in cardboard Box with outer box label. Cell Marque, Rocklin, CA 95677, intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in section of formalin fixed, paraffin embedded tissue section using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualifi...
Source: Medical Device Recalls - March 6, 2012 Category: Medical Equipment Source Type: alerts

Novomedicus Llc - Artificial Bur Fascia Prothesis - Class 2 Recall
The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing. Contents: Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. Caution: Federal Law restricts this device to sale by or on the order of a physician. Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. Manufactured For: NOVOMEDICUS, LLC P.O. Box 2105 Nokomis, FL 34274 Phone 941.375.4108 Email:Support@novomedicus.com The Wittmann Patch is used for a fascia expander prosthesis to temporarily close the abdominal cavity w...
Source: Medical Device Recalls - January 27, 2012 Category: Medical Equipment Source Type: alerts

Novomedicus Llc - Bur Hypo Pack - Class 2 Recall
The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only. Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. 2. 60cm x 85 cm Steri Drape 3. Drain with Connector 4. 4 x Gauze Rolls Caution: Federal Law restricts this device to sale by or on the order of a physician. Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. The Wittmann Patch is used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to pr...
Source: Medical Device Recalls - January 27, 2012 Category: Medical Equipment Source Type: alerts

Cardinal Health - Presource Custom Sterile Surgical and Procedure Kits - Class 2 Recall
Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components: a) Silastic Tubing, 0.062 ID x 0.032 Wall x 50 Ft, component C-602-285, vendor part number SFM3-2850; b) Silastic Tubing, 0.040 ID x 0.023 Wall x 50 Ft, component C-SFM3-2050, vendor part number SFM3-2050; c) Pathology Container with Lid, 8 oz., component 3701Z, vendor part number 3701; d) Silicone Tubing, 0.187 ID x 0.313 OD x 50 Ft., component C-31010SG, vendor part number 31010;...
Source: Medical Device Recalls - January 26, 2012 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath GUI - Class 2 Recall
SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2011 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. - Class 2 Recall
SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2011 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath GUI - Class 2 Recall
SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2011 Category: Medical Equipment Source Type: alerts

Leica Microsystems, Inc. - Leica Bond ReadytoUse Primary Antibody Epithelial Membrane Antigen (GP1.4) - Class 3 Recall
Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0035; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. Epithelial Membrane Antigen (GP1.4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human epithelial membrane antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond-max system. The clinical interpretation of any staining or its absence s...
Source: Medical Device Recalls - September 9, 2011 Category: Medical Equipment Source Type: alerts

Leica Microsystems, Inc. - Leica Bond ReadytoUse Primary Antibody CDX2 (AMT28); - Class 3 Recall
Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The CDX2 (AMT28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CDX2 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper con...
Source: Medical Device Recalls - September 9, 2011 Category: Medical Equipment Source Type: alerts

Cell Marque Corporation - CD99 (H0361.1) Mouse Monoclonal Antibody. - Class 3 Recall
Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician. (S...
Source: Medical Device Recalls - August 31, 2011 Category: Medical Equipment Source Type: alerts

Ventana Medical Systems Inc - iView DAB Detection Kit - Class 2 Recall
iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by m...
Source: Medical Device Recalls - July 1, 2011 Category: Medical Equipment Source Type: alerts

Ventana Medical Systems Inc - ultraView Universal DAB Detection Kit - Class 2 Recall
ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be com...
Source: Medical Device Recalls - July 1, 2011 Category: Medical Equipment Source Type: alerts

Ge Healthcare It - GE Centricity Laboratory Instrument Interface Data Innovations Instrument Manager Software - Class 2 Recall
GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010. The Centricity Laboratory is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distrib...
Source: Medical Device Recalls - June 14, 2011 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - iCross Coronary Imaging Catheter - Class 1 Recall
Boston Scientific, Atlantis ¿ SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, USE BY 2011-05, REF 39014, UPN H749390140, Sterile R Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 The intended use as stated in Japan Shonin 21200BZY00484000: This product is an imaging catheter with built-in ultrasonic transducer that sends ultrasound waves inside the blood vessel to perform B-mode ultrasonagraphy. The indications for use as stated in the 510(k) and DFU 90606867: The Atlantis coronary catheters are intended for ultrasound examination of coronary intravascular patholo...
Source: Medical Device Recalls - June 10, 2011 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - Atlantis(r) SR Pro 2, 40 MHz Coronary Imaging Catheter - Class 1 Recall
Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 10, 2011 Category: Medical Equipment Source Type: alerts

Cardinal Health Inc - MediVac Speciment Sock - Class 3 Recall
Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient. Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection ...
Source: Medical Device Recalls - March 30, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
TOTAL ASR FEM IMP SIZE 41, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixat...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 49, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 59, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 63, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
TOTAL ASR FEM IMP SIZE 45, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixat...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 39, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 47, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 61, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 55, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 53, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 57, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
TOTAL ASR FEM IMP SIZE 43, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixat...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Depuy Orthopaedics, Inc. - DEPUY ASR RESURFACING FEMORAL HEADS - Class 2 Recall
ASR FEMORAL IMPLANT SIZE 51, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fix...
Source: Medical Device Recalls - March 24, 2011 Category: Medical Equipment Source Type: alerts

Ge Healthcare It - GE Centricity Laboratory - Class 2 Recall
GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. The Centricity Laboratory software is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through...
Source: Medical Device Recalls - February 15, 2011 Category: Medical Equipment Source Type: alerts

Vital Images, Inc. - Vital Connect - Class 2 Recall
Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each oth...
Source: Medical Device Recalls - February 2, 2011 Category: Medical Equipment Source Type: alerts

Ge Healthcare It - GE Centricity Laboratory Instrument Interface Software - Class 2 Recall
GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 22, 2010 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath GUI Releases 3.17 through 4.1.0. - Class 2 Recall
SoftPath GUI Releases 3.17 through 4.1.0. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distribution Dates: Version 3.17.5 10/14/2003. Version 3.17.6 03/28/2003. Version 3.17.7 07/02/2003. Version 3.17.8 03/03/2004. Version 4.1.0 07/03/2003. Version 4.1.1 10/03/2003. Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2010 Category: Medical Equipment Source Type: alerts

Alphatec Spine, Inc. - Novel Spinal Spacer System - Class 2 Recall
Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - November 12, 2009 Category: Medical Equipment Source Type: alerts

GE Healthcare Integrated IT Solutions - Centricity TriWin Laboratory - Class 2 Recall
Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - May 15, 2009 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - Atlantis PV Peripheral Imaging Catheter, - Class 2 Recall
Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - January 28, 2009 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - iLab Ultrasound Imaging System, models 120INS and 240INS - Class 2 Recall
Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasound examination of intravascular pathology. Manufactured by Boston Scientific Corporation, Fremont, CA. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - December 16, 2008 Category: Medical Equipment Source Type: alerts

Sunquest Information Systems, Inc. - Sunquest Laboratory - Class 2 Recall
Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3. Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection management, specimen tracking, and use with microbiology and molecular diagnostics. Key capabilities include: 1) Autoverify results directly from analyzers and reference laboratories 2) Track tubes and containers from order to final disposition 3) Monitor key metrics such as turnaround time and utilization using management reports 4) Produce pathology results with Structured Reports 5) Suggest microbiology workups online according to ...
Source: Medical Device Recalls since July 07, 2006 - October 31, 2008 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath GUI Release Software Versions 3.17 and 4.1 - Class 2 Recall
SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - September 22, 2008 Category: Medical Equipment Source Type: alerts

Ventana Medical Systems Inc - Ventana Image Analysis System (VIAS) - Class 2 Recall
Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, AZ 85755 (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - March 18, 2008 Category: Medical Equipment Source Type: alerts

General Electric Med Systems LLC - GE LightSpeed RT16 CT Scanner System - Class 2 Recall
The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of obese patients, up to and including the obese population (BMI > 40). When used in the LightSpeed RT 16 configuration, the system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - February 15, 2007 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath - Class 2 Recall
Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinicial documentation and data processing. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - August 2, 2006 Category: Medical Equipment Source Type: alerts

SCC Soft Computer - SoftPath - Class 2 Recall
SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3 (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - August 1, 2006 Category: Medical Equipment Source Type: alerts