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Field Safety Notices June 2014

Notice type: 3rd Party Publications

Date: 08/07/2014

  

Further Information:

Monthly list of Field Safety Notices - June 2014

Alere
Alere Triage® BNP Test

ArcRoyal 
Custom Procedure Trays (CPTs)

Bard Medical Division, C. R. Bard, Inc. 
Bard® Hydrogel Coated Prostatic Catheters

BioMerieux 
UF-1000i

Bio-Rad
Biotestcell I8, Biotestcell I11, Biotestcell I11E

Bracco Engineering
CT Expres™ hand switch

DePuy Synthes
Anspach attachments & handpieces using the STERRAD(R) 100S sterilization process

DePuy Synthes 
Application instrument for Sternal Zipfix

Gambro Industries 
PRISMA, PRISMAFLEX, PRISMARS, X-MARS, ADSORBA, SEPTEX and OXIRIS sets

GE Healthcare 
Vital Signs enFlow IV Fluid Warmer Model 100

GE Healthcare Systems
Compact Airway Modules: E-CaiO-00 E-CaiOV-00 E-CAiOVX-00 E-CO-00 E-COV-00 and E-COVX-00

GE Healthcare Systems - Wauwatosa 
CARESCAPE Monitor B850, B650 or B450

GE Medical Systems LLC
"Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w equipped with GEM option, Discovery MR750w and Discovery MR750w equipped with GEM option"

Heraeus Kulzer
GLUMA Desensitizer PowerGel

Integra LifeSciences Services 
Integra® LED Battery Charger, Single Bay

Intelerad Medical Systems Inc. 
INTELEPACS Versions 3.8.1 and up

Invacare
Fixed Backrest for Mobile Shower and Toilet Commode Aquatec® Ocean, Ocean VIP and Ocean E-VIP

McKesson Medical Imaging Company
Horizon Medical Imaging (HMI) products versions 4.6.1 to 11.9 and McKesson Radiology 12.0

Medline International Germany GmbH
Basin Liners

Microtek Medical BV
Basin Liner

Philips Healthcare 
Gel-E Donut and Squishon 2 Gel-filled Products

Philips Medical Systems Nederland B.V.
"Ingenia, Intera Achieva and Achieva dStream MR systems using R5.1.1 and R5.1.2 version of software"

Radiometer Medical Aps
AQURE system FSN 1

Radiometer Medical Aps
AQURE system FSN 2

Roche 
Accu-Chek Mobile System FSN 1

Roche 
Accu-Chek Mobile System FSN 2 

Sentra Medical Limited 
IV Fluid Infusion Set

Serosep Limited
Entericbio realtime Gastro Panel I

Siemens AG Healthcare, Geschäftsgebiet Radiation Oncology 
PRIMUS, ONCOR, ARTISTE linacs

Siemens Healthcare Diagnostics 
ADVIA Centaur / Centaur XP / Centaur CP Troponin Ultra

Stryker Instruments 
Cutting Accessories that are used with the Elite™ Attachments

Ultimate Healthcare 
Pumps for the Tamora and Tamora Plus pressure relief mattresses

Varian Medical Systems 
C-Series High Energy Linear Accelerator

Vascutek Limited 
Aspire Aortic Valve (A44-xx), Aspire Mitral Valve (M55-xx)

Williams Medical Supplies Limited 
667455 Skin Graft Knife Blades


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