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Synthes USA HQ, Inc. - Synthes Minimally Invasive Reduction Screw System (MIRS) - Class 2 Recall
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Source: Medical Device Recalls - October 1, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent - Class 2 Recall
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Source: Medical Device Recalls - October 1, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Slotted Femoral Head Provisional - Class 2 Recall
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Neck Taper - Class 2 Recall
12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Slotted Femoral Head Provisional - Class 2 Recall
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - VerSys Femoral Head Provisional - Class 2 Recall
00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Slotted Femoral Head Provisional - Class 2 Recall
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Neck Taper - Class 2 Recall
12/14 Neck Taper 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometery and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Slotted Femoral Head Provisional - Class 2 Recall
00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28 00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Neck Taper - Class 2 Recall
12/14 Neck Taper 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - VerSys Femoral Head Provisional - Class 2 Recall
00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry y and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - MIS Slotted Femoral Head Provisional - Class 2 Recall
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - VerSys - Class 2 Recall
00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - Optilock - Class 2 Recall
Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Stryker Howmedica Osteonics Corp. - Stryker Orthopaedics - Class 2 Recall
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - Optilock - Class 2 Recall
Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Stanley Security Solutions, Inc. - Tabs Professional Monitor, Model 25022 - Class 2 Recall
Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Stanley Security Solutions, Inc. - Tabs Professional Voice Monitor, Model 25223 - Class 2 Recall
Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Stanley Security Solutions, Inc. - Tabs Professional Monitor, Model 25025 - Class 2 Recall
Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - Persona Personalized Knee System - Class 2 Recall
Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Stanley Security Solutions, Inc. - Tabs Professional Monitor, Model 25023 - Class 2 Recall
Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Class 2 Recall
Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Stanley Security Solutions, Inc. - Tabs Professional Voice Monitor, Model 25222 - Class 2 Recall
Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Eos Imaging Inc - EOS System - Class 2 Recall
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

Linvatec Corp. dba ConMed Linvatec - 24K Arthroscopy Outflow/Suction Tubing Set - Class 2 Recall
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
Source: Medical Device Recalls - September 27, 2012 Category: Medical Equipment Source Type: alerts

KCI USA, Inc. - BariAir Therapy System - Class 2 Recall
BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large ...
Source: Medical Device Recalls - September 27, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - System, Xray Stationary - Class 2 Recall
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
Source: Medical Device Recalls - September 27, 2012 Category: Medical Equipment Source Type: alerts

Mc-NEIL-PPC, Inc. - KY LIQUIBEADS Vaginal Moisturizer - Class 2 Recall
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
Source: Medical Device Recalls - September 27, 2012 Category: Medical Equipment Source Type: alerts

Micro Therapeutics Inc, Dba Ev3 Neurovascular - Marathon Flow Directed Micro Catheter - Class 2 Recall
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Source: Medical Device Recalls - September 27, 2012 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - TSX301A/2 Aquilion One CT System - Class 2 Recall
TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
Source: Medical Device Recalls - September 27, 2012 Category: Medical Equipment Source Type: alerts

Micro Therapeutics Inc, Dba Ev3 Neurovascular - UltraFlow HPC Flow Directed Micro Catheter - Class 2 Recall
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Source: Medical Device Recalls - September 27, 2012 Category: Medical Equipment Source Type: alerts

Alcon Research, LTD. - Alcon 23G NonValved Trocar Cannula and Infusion Cannula - Class 2 Recall
This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraoc...
Source: Medical Device Recalls - September 27, 2012 Category: Medical Equipment Source Type: alerts

Invacare Corporation - IFit Shower Chair - Class 2 Recall
Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
Source: Medical Device Recalls - September 26, 2012 Category: Medical Equipment Source Type: alerts

Imaging Sciences International, LLC - DEXIS Imaging Suite - Class 2 Recall
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Source: Medical Device Recalls - September 26, 2012 Category: Medical Equipment Source Type: alerts

Greatbatch Medical - Boston Scientific, Z Flex 270, Steerable Sheath - Class 2 Recall
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
Source: Medical Device Recalls - September 26, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Varian brand Eclipse Treatment Planning System - Class 2 Recall
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
Source: Medical Device Recalls - September 26, 2012 Category: Medical Equipment Source Type: alerts

Integra Limited - MAYFIELD Horseshoe Gel Pads Right Gel Pad - Class 2 Recall
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between t...
Source: Medical Device Recalls - September 26, 2012 Category: Medical Equipment Source Type: alerts

Integra Limited - MAYFIELD Horseshoe Gel Pads Left Gel Pad - Class 2 Recall
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between th...
Source: Medical Device Recalls - September 26, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR - Class 2 Recall
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Source: Medical Device Recalls - September 26, 2012 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere Triage TOX Drug Screen 9 Panel - Class 2 Recall
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
Source: Medical Device Recalls - September 26, 2012 Category: Medical Equipment Source Type: alerts

Applied Medical Resources Corp - Irrigation Catheters - Class 2 Recall
Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.
Source: Medical Device Recalls - September 25, 2012 Category: Medical Equipment Source Type: alerts

Abbott Vascular - Armada Catheters - Class 2 Recall
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Source: Medical Device Recalls - September 25, 2012 Category: Medical Equipment Source Type: alerts

Neomend Inc - Progel Pleural Air Leak Sealant - Class 2 Recall
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.
Source: Medical Device Recalls - September 25, 2012 Category: Medical Equipment Source Type: alerts

Applied Medical Resources Corp - Biliary Catheters - Class 2 Recall
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
Source: Medical Device Recalls - September 25, 2012 Category: Medical Equipment Source Type: alerts

Applied Medical Resources Corp - Embolectomy Catheters - Class 2 Recall
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CAT...
Source: Medical Device Recalls - September 25, 2012 Category: Medical Equipment Source Type: alerts

Hologic, Inc. - Hologic Fluoroscan Mini CArm Model with InSight FD - Class 2 Recall
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Source: Medical Device Recalls - September 25, 2012 Category: Medical Equipment Source Type: alerts

Hologic, Inc. - Hologic Fluoroscan Mini CArm Model with InSight2 - Class 2 Recall
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
Source: Medical Device Recalls - September 25, 2012 Category: Medical Equipment Source Type: alerts