Medical Equipment Alerts 
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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 5.
DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conf...
Source: Medical Device Recalls - January 24, 2013 Category: Medical Equipment Source Type: alerts
Abbott Laboratories - ARCHITECT 25OH Vitamin D Reagent Kit - Class 2 Recall
ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA, Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany, product of Spain; Product Usage:The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.
Source: Medical Device Recalls - January 23, 2013 Category: Medical Equipment Source Type: alerts
Becton Dickinson & Co. - BD MAX (tm) (6 channel) Instruments - Class 2 Recall
BD MAX (tm) (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA*** The BD MAX" System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial and research settings. The MAX reader assembly is the optics component of the instrument that translates PCR amplification into curves. The cu...
Source: Medical Device Recalls - January 22, 2013 Category: Medical Equipment Source Type: alerts
AMS Innovative Center - San Jose - GreenLight HPS (High Performance System); GreenLight XPS ( Xcelerated Performance System) - Class 2 Recall
GreenLight HPS (High Performance System) GreenLight XPS ( Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center - Silicon Valley, 3070 Orchard Drive, San Jose, CA 95134. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasis. The entire laser unit and controls are contained in a single console that is connected to external electricity and are required to meet IEC 60601.
Source: Medical Device Recalls - January 22, 2013 Category: Medical Equipment Source Type: alerts
Becton Dickinson & Co. - BBL Crystal Enteric/Nonfermenter ID Kit - Class 2 Recall
BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, labeled in part ***Becton, Dickinson and Company, Sparks MD 21152*** The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
Source: Medical Device Recalls - January 20, 2013 Category: Medical Equipment Source Type: alerts
IDS (Immunodiagnostic Systems Ltd.) - Class 2 Recall
25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.
Source: Medical Device Recalls - January 18, 2013 Category: Medical Equipment Source Type: alerts
Roche Diagnostics Operations, Inc. - Roche COBAS INTEGRA 400 and 400 plus Analyzer - Class 3 Recall
Roche COBAS INTEGRA 400 and 400 plus Analyzer The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Source: Medical Device Recalls - January 18, 2013 Category: Medical Equipment Source Type: alerts
Vycor Medical, Inc. - Vycor Medical ViewSite Brain Access System - Class 1 Recall
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts
Stryker Howmedica Osteonics Corp. - Hoffman LRF Wire Bolt - Class 2 Recall
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts
Bausch and Lomb, Incorporated - Bausch & Lomb Disposable 27G cannula - Class 1 Recall
Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts
Spacelabs Healthcare, Llc - Spacelabs Smart Disclosure System, Model 92810 - Class 2 Recall
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, includin...
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts
Quanta System, S.p.A. - Eterna Giovinezza System - Class 2 Recall
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts
Quanta System, S.p.A. - Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser - Class 2 Recall
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or perma...
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts
Quanta System, S.p.A. - QPlus T Powered Laser Surgical Instrument - Class 2 Recall
Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - GranuFlo Dry Acid Concentrate - Class 3 Recall
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts
Perkinelmer - Perkin Elmer NEONATAL TOTAL GALACTOSE KIT - Class 2 Recall
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Source: Medical Device Recalls - January 16, 2013 Category: Medical Equipment Source Type: alerts
Perkinelmer - Perkin Elmer NEOBASE NONDERIVATIZED MSMS KIT - Class 2 Recall
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Source: Medical Device Recalls - January 16, 2013 Category: Medical Equipment Source Type: alerts
Perkinelmer - Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM - Class 2 Recall
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in...
Source: Medical Device Recalls - January 16, 2013 Category: Medical Equipment Source Type: alerts
Perkinelmer - Perkin Elmer DBS MICROPLATE - Class 2 Recall
DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
Source: Medical Device Recalls - January 16, 2013 Category: Medical Equipment Source Type: alerts
Perkinelmer - Perkin Elmer Microplate - Class 2 Recall
Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
Source: Medical Device Recalls - January 16, 2013 Category: Medical Equipment Source Type: alerts
DePuy Spine, Inc. - DePuy Spine EXPEDIUM Offset Torque Wrench - Class 2 Recall
DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
Source: Medical Device Recalls - January 16, 2013 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Computed Tomography XRay System Brilliance Workspace Portal - Class 2 Recall
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data.
Source: Medical Device Recalls - January 16, 2013 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance 64 and Ingenuity Computed Tomography (CT) - Class 2 Recall
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Source: Medical Device Recalls - January 15, 2013 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - Sarns highflow aortic arch cannula - Class 2 Recall
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - Sarns flexible arterial cannula - Class 2 Recall
Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - Sarns highflow aortic arch cannula - Class 2 Recall
Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - Sarns flexible arterial cannula - Class 2 Recall
Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - Sarns highflow aortic arch cannula - Class 2 Recall
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - Sarns flexible arterial cannula - Class 2 Recall
Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) - Class 2 Recall
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
Source: Medical Device Recalls - January 10, 2013 Category: Medical Equipment Source Type: alerts
Merit Medical Systems, Inc. - Merit Medical's Custom Procedural Tray - Class 2 Recall
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F. Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Source: Medical Device Recalls - January 10, 2013 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Siemens Emit(R) tox(TM) Serum Calibrators - Class 3 Recall
Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.
Source: Medical Device Recalls - January 10, 2013 Category: Medical Equipment Source Type: alerts
Maquet Cardiovascular, LLC - CARDIOSAVE IntraAortic Balloon Pump - Class 2 Recall
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
Source: Medical Device Recalls - January 9, 2013 Category: Medical Equipment Source Type: alerts
Stryker Communications, Inc. - Visum Halogen Surgical Light - Class 2 Recall
(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel & Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel & Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope ...
Source: Medical Device Recalls - January 9, 2013 Category: Medical Equipment Source Type: alerts
Zimmer, Inc. - TM Ardis Interbody System Inserter - Class 2 Recall
The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.
Source: Medical Device Recalls - January 9, 2013 Category: Medical Equipment Source Type: alerts
Zoll Circulation, Inc. - AutoPulse Resuscitation System - Class 2 Recall
AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Source: Medical Device Recalls - January 9, 2013 Category: Medical Equipment Source Type: alerts
Biomet, Inc. - PTHYBRID - Class 2 Recall
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Source: Medical Device Recalls - January 9, 2013 Category: Medical Equipment Source Type: alerts
Advanced Sterilization Products - STERRAD NX Cassettes - Class 2 Recall
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
Source: Medical Device Recalls - January 9, 2013 Category: Medical Equipment Source Type: alerts
