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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