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Summary of Field Safety Notices - May 2021
Notice type:
3rd Party Publications
Date:
02/06/2021
Further Information:
Summary of Field Safety Notices - May 2021
Acutronic Medical Systems AG
Fabian HFO, +nCPAP evolution and Therapy evolution
Advice regarding a device modification. HPRA Ref: V46470
Fabian Fabian +nCPAP evolution - Updated IFU
Advice regarding a software upgrade. HPRA Ref: V44941
Fabian HFO - End User Release Note
Advice regarding a software upgrade. HPRA Ref: V44941
Fabian HFO - Updated IFU
Advice regarding a software upgrade. HPRA Ref: V44941
Fabian Therapy +nCPAP evolution - End User Release Note
Advice regarding a software upgrade. HPRA Ref: V44941
Angiomed GmbH & Co. Medizintechnik KG
Venovo Venous Stent System
Advice regarding a device removal. HPRA Ref: V46623
Bausch and Lomb
Biotrue® contact lens solution, ReNu® MPS Multi-purpose solution sensitive eyes, ReNu® MultiPlus contact lens solution, Boston®cleaner,
Boston® conditioning solution, Boston® Simplus Multi-Action contact lens solution, Sensitive Eyes®cleaner, Boston® conditioning solution,
Boston® Simplus Multi-Action contact lens solution, Sensitive Eyes® contact lens solution, EasySept® contact lens solution,
Ophtaxia® eye wash solution, Sensitive Eyes® eye lubricant solution
Advice regarding a device removal. HPRA Ref: V46496
Baxter Healthcare SA
PrisMax, V2, ROW
Advice regarding a software upgrade. HPRA Ref: V45593
Medication Delivery and Renal Care Products
Advice regarding a device removal. HPRA Ref: V46645
BD
"T34 TM Ambulatory Syringe Pumps, 3rd Edition"
Advice regarding a software upgrade. HPRA Ref: V46458
BD Venflon Pro I.V. Cannula
Advice regarding a device removal. HPRA Ref: V46608
Beaver Visitec International Ltd
BVI CustomEyes Kits and Malosa Kits
Advice regarding the use of the device. HPRA Ref: V45738
Beaver-Visitec International
BVI CustomEyes Kits and Malosa Kits
Advice regarding a device removal. HPRA Ref: V46585
Becton Dickinson
BD Venflon Pro Safety I.V. Cannula
Advice regarding a device removal. HPRA Ref: V45817
bioMerieux SA
MYLA
Advice regarding a software upgrade. HPRA Ref: V46606
Bosch Healthcare Solutions GmbH
SARS-CoV-2 and SARS-CoV-2 Pooling
Advice regarding a software upgrade. HPRA Ref: V46554
Diffulplast S.r.L.
TPN Bag Multilayer
Advice regarding the use of the device. HPRA Ref: V46577
Draeger
Evita V800, Evita V600, Babylog VN800 and Babylog VN600 with SW1.05.00 and lower - FSN 2
Advice regarding the use of the device. HPRA Ref: V46376
Hillrom
Affinity 4 Birthing Bed
Advice regarding a device modification. HPRA Ref: V46640
Institut Straumann AG
SCS Screw driver for Ratchet, short/long
Advice regarding a device removal. HPRA Ref: V46636
KARL STORZ SE & Co. KG
10973HD – Video Mediastinoscope
Advice regarding a device removal. HPRA Ref: V46589
Lagis Enterprise Co., Ltd.
Endoscopic Instrument Scissors - Metzenbaum Curve
Advice regarding a device removal. HPRA Ref: V46614
Leica Biosystems Newcastle Limited
BOND Wash Solution 10X Concentrate, ER1 and ER2
Advice regarding the use of the device. HPRA Ref: V46549
Lima Corporate SPA
Multigen Plus H Knee system
Advice regarding the use of the device. HPRA Ref: V46543
Maquet Cardiopulmonary GmbH
Tight Caps accessory of the Neonatal Venous Hardshell Cardiotomy Reservoir with QUADROX-I Neonatal Oxygenator with or without coating and Neonatal Venous Hardshell Cardiotomy Reservoir
Advice regarding a device removal. HPRA Ref: V46557
Maquet Critical Care AB
SoKINOX, SERViNO
Advice regarding a software upgrade. HPRA Ref: V46572
Medtronic
CareLink Programmer; CareLink Encore Programmer
Advice regarding a software upgrade. HPRA Ref: V37585
Valiant Navioan Aortic Stent Graft - FSN 2
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V45767
Philips Medical Systems
Xper Flex Cardio Physiomonitoring System
Advice regarding a software upgrade. HPRA Ref: V46315
Sentinel CH, SpA
ACE Control Set
Advice regarding the use of the device. HPRA Ref: V46512
Siemens Healthcare Diagnostics
Atellica CH 930 Analyzer
Advice regarding the use of the device. HPRA Ref: V46503
Siemens Healthcare Diagnostics Inc.
Atellica CH 930 Analyzer, Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer
Advice regarding a device modification. HPRA Ref: V46573
Smith & Nephew Medical Ltd
JELONET 5X5CM CTN 50
Advice regarding a device removal. HPRA Ref: V46674
Stryker Trauma GmbH
Nail insertion sleeve, elastic T2 Tibia SPI
Advice regarding a device removal. HPRA Ref: V46639
Trinity Biotech
Captia™ NMT Syphilis IgM
Advice regarding a device removal. HPRA Ref: V46530
Welch Allyn
WelchAllyn GS777 Wall Transformer (all models) and PRO BP 3400 (handheld, desk mount, wall mount models)
Advice regarding the use of the device. HPRA Ref: V46403
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Date Printed: 24/06/2021