Siemens Medical Solutions USA, Inc - Siemens Syngo Dynamics - Class 2 Recall
Syngo Dynamics Product Usage: Syngo Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical...
View ArticleSiemens Healthcare Diagnostics - ADVIA Centaur XP Immunoassay - Class 2 Recall
ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
View ArticleOrtho Development Corporation - PSC Femoral Nonporous Rt Sz 6 - Class 2 Recall
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Product Usage: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint....
View ArticleMckesson Medical Immaging - Picture Archive Communication System (PACS) -...
McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images,...
View ArticleFresenius Medical Care Holdings, Inc. - Revision K Actuator Test Boards -...
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
View ArticleBiomet, Inc. - ExploR 7x26mm Modular Radial Stem - Class 2 Recall
ExploR 7x26mm Modular Radial Stem Product Usage: Biomet manufactures a variety of elbow joint Radial Head and Modular Radial Head prostheses intended for primary and revision joint athroplasty for use...
View ArticleFresenius Medical Care Holdings, Inc. - Fresenius 2008T Hemodialysis Machine...
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and...
View ArticleBaxter Corporation Englewood - ABACUS TPN Calculation Software - Class 1 Recall
ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ -...
View ArticleHeartWare Inc - HeartWare Ventricular Assist System - Class 2 Recall
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage...
View ArticleBaxter Corporation Englewood - RAPIDFILL Syringe Strip - Class 2 Recall
RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler,(ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip,...
View ArticleCareFusion 303, Inc. - Alaris Pump model 8100 - Class 1 Recall
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the...
View ArticleInterValve Inc - InterValve V8 Balloon Aortic Valvuloplasty Catheter - Class...
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Sterilized by ethylene oxide gas. The V8 Transluminal BAV Catheter is indicated for Balloon...
View ArticleSiemens Medical Solutions USA, Inc - syngo Imaging XS - Class 2 Recall
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images....
View ArticleThe Anspach Effort, Inc. - Anspach Irrigation Clip 40 - Class 2 Recall
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and...
View ArticleHospira Inc. - EXTENSION SET; For Bladder Irrigation or Urinary Drainage -...
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira...
View ArticleHospira Inc. - LARGE BORE YIRRIGATION SET - Class 2 Recall
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible...
View ArticleHospira Inc. - CYSTOSCOPY/IRRIGATION SET - Class 2 Recall
LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product...
View ArticleHospira Inc. - TUR YSet - Class 2 Recall
LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use...
View ArticleHospira Inc. - 4LEAD TUR IRRIGATION SET - Class 2 Recall
LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira...
View ArticlePhilips Medical Systems, Inc. - IntelliVue Patient Monitoring - Class 2 Recall
IntelliVue Patient Monitoring Product Usage: The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and...
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