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Summary of Field Safety Notices - November 2018
Notice type:
3rd Party Publications
Date:
04/12/2018
Further Information:
Abbott Ireland, Diagnostics Division
Alinity i - Various Products
Advice regarding a device removal. HPRA Ref: V37999
Abiomed Europe GmbH
Impella 2.5 and Impella CP heart pumps
Advice regarding the use of the device. HPRA Ref: V37782
Alere Scarborough, Inc.
Alere™ BinaxNOW® Legionella Urinary Antigen Card used in conjunction with the Alere™ Reader
Advice regarding a device modification. HPRA Ref: V37863
Arthrex GmbH- Munich
DrillSaw Sports 400 System Li-ion Battery Housing for AR-400
Advice regarding a device removal. HPRA Ref: V37316
Bard Peripheral Vascular (BPV)
BARD® ePTFE Small Beading Vascular Graft Products
Advice regarding the use of the device. HPRA Ref: V37890
Boston Scientific Corporation
SQ-RX® pulse generator, model 1010 - subcutaneous implantable cardioverter defibrillator (S-ICD)
Advice regarding the use of the device. HPRA Ref: V37893
ConvaTec Limited
Suction Catheters, Gastro-enteral Tubes, Intermittent Urology Catheters and sterile Urine Drainage Bags
Advice regarding a device removal. HPRA Ref: V36438
Delgania Silicone Ltd
Mon-a-Therm™ Foley Catheters with Temperature Sensors
Advice regarding a device removal. HPRA Ref: V36900
Dezania Silicone Ltd
Mon-a-Therm™ Foley catheters with temperature sensors
Advice regarding a device removal. HPRA Ref: V36900
Eurotrol B.V
HemoTrol Normal (Level 2), HemoTrol High (Level 3),CueSee® tHb Level 2 & Level 3
Advice regarding a device removal. HPRA Ref: V37811
Fast Track Diagnostics Luxembourg S.à.r.l.
FTlyo 2+.1 Respiratory pathogens 21 plus, FTlyo 2P.3 Respiratory pathogens 33, FTlyo 48.1 FLU/HRSV v.2, FTlyo 56.1 HCoV v.1
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37936
Gambro Lundia AB
CWP 800 RO1 220-240V/ 380-415V 50Hz & CWP 800 HW 220-240V/ 380-415V 50Hz
Advice regarding a device modification. HPRA Ref: V37991
GE Healthcare
Aisys & Aisys CS2 anesthesia devices
Advice regarding a software upgrade. HPRA Ref: V37909
GE Healthcare Finland Oy
CARESCAPE B450, B650, and B850 (Bx50) monitors
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37916
Intuitive Surgical
da Vinci® EndoWrist® Monopolar Curved Scissors
Advice regarding a device removal. HPRA Ref: V37822
Linkage Biosciences Inc
LinkSeq HLA ABCDRDQA1DQB1/ABCDRDQDP+/SABR/DRDQDP
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37844
LivaNova Deutschland GmbH
Heater-cooler (1T), Heater-cooler 3T
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37768
Löwenstein Medical Technology GmbH + Co. KG
SOMNObalance, SOMNOsoft 2, prisma SOFT and prisma SMART
Advice regarding a device modification. HPRA Ref: V37270
Maquet Cardiopulmonary GmbH
QUADROX-i Neonatal Microporous Membrane Oxygenator FSN 1
QUADROX-i Neonatal Microporous Membrane Oxygenator FSN 2
Advice regarding a device removal. HPRA Ref: V37592
Maquet Cardiopulmonary GmbH
Heater-Cooler Unit HCU 40
Advice regarding a device modification. HPRA Ref: V38051
Medtronic Inc
CareLink Programmer; CareLink Encore Programmer
Advice regarding the use of the device. HPRA Ref: V37585
Novacor
R.Test Evolution 4
Advice regarding a software upgrade. HPRA Ref: V37965
Ohmeda Medical
Giraffe OmniBed Carestation, Giraffe Incubator Carestation, Giraffe Warmer, Panda iRes Warmer, Panda Freestanding Warmer and Panda Wall Mount
Advice regarding the use of the device. HPRA Ref: V37898
Ohmeda Medical a division of Datex-Ohmeda
Giraffe OmniBed
Advice regarding the use of the device. HPRA Ref: V37937
Olympus Medical System Corporation
Various endoscope models
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37987
Philips Medical Systems
HeartStart MRx Lithium Ion Module (Rechargeable)
Advice regarding a device removal. HPRA Ref: V37853
Philips Medical Systems (Cleveland) Inc.
Brilliance 6, Brilliance 10, Brilliance 16 & 16 Power, Brilliance 40, Brilliance 64
Advice regarding a device modification. HPRA Ref: V37804
Randox Laboratories Limited
Liquid Protein Calibrators
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37970
Randox Laboratories Ltd
Evidence Investigator FSN
Evidence Investigator Attachment
Advice regarding a software upgrade. HPRA Ref: V37943
Roche Diagnostics GmbH
Accu-Chek Insight insulin pump system
Advice regarding the use of the device. HPRA Ref: V37471
Stago
STACLOT® LA
Advice regarding a device removal. HPRA Ref: V38029
The Binding Site Group
Human IgM Kit for use on SPAPLUS
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37832
Thermo Fisher Scientific Microbiology
ThermoScientific Oxoid Brilliance VRE Agar
Advice regarding the use of the device. HPRA Ref: V37925
Vygon
DUALSTOP Stoppers
Advice regarding a device removal. HPRA Ref: V38078
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Date Printed: 04/12/2023