My HPRA: Register

Summary of Field Safety Notices - March 2022

Notice type: 3rd Party Publications

Date: 04/04/2022

  

Further Information:
Abbott GmbH
Alinity i Homocysteine Reagent Kit
Advice regarding the use of the device. HPRA Ref: V50796


Acutronic Medical Systems AG
Fabian HFOi
Advice regarding a software upgrade. HPRA Ref: V50809


Atrium Medical Corporation
Atrium Advanta V12 covered stent system
Advice regarding the use of the device. HPRA Ref: V50671


B. Braun
Simpson Shelf Pessary
Advice regarding a device removal. HPRA Ref: V50767


B.Braun Melsungen AG
Vasofix® Safety
Advice regarding a device removal. HPRA Ref: V50669


Baxter Healthcare SA
PrisMax V2 ROW, PrisMax V3 ROW
Advice regarding a software upgrade. HPRA Ref: V50741


Baxter Healthcare SA
ARTISET HD DNL HC 
Advice regarding a device removal. HPRA Ref: V50758


Becton Dickinson S.A.
BD Plastipak™ Luer-Lok™ Syringe
Advice regarding changes/updates made to instructions for use. HPRA Ref: V50764


Bio-Rad Medical Diagnostics GmbH
Anti-Lua (LU1)
Advice regarding a device removal. HPRA Ref: V50738


Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope
Advice regarding the use of the device. HPRA Ref: V50528


Covidien LLC
Puritan Bennett 980 Ventilator System
Advice regarding a software upgrade. HPRA Ref: V50698


Edwards Lifesciences LLC
FORE-SIGHT ELITE Tissue Oximeter Module and FORE-SIGHT ELITE
Advice regarding the use of the device. HPRA Ref: V50572


GE Healthcare
Signa TwinSpeed, Signa Excite, Signa HD
Advice regarding the use of the device. HPRA Ref: V50672


GE Medical Systems SCS
Revolution CT, Revolution CT ES, Revolution Apex, and Revolution CT with Apex Edition Systems
Advice regarding a software upgrade. HPRA Ref: V50692


Intuitive Surgical, Inc.
da Vinci X/Xi Vessel Sealer Extend (PN 480422) and SynchroSeal (PN 480440) Instruments
Advice regarding the use of the device. HPRA Ref: V50658


Intuitive Surgical, Inc.
SureForm 45, SureForm 45 Curved-Tip, SureForm 60
Advice regarding the use of the device. HPRA Ref: V50837


Medtronic
IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheters
Advice regarding a device removal. HPRA Ref: V50730


Merit Medical 
Access-9™ and AccessPLUS™ Hemostasis Valves
Advice regarding a device removal. HPRA Ref: V50625


Microbiologics, Inc.
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Advice regarding a device removal. HPRA Ref: V50704


Philips Medical
Azurion R1.x
Advice regarding a software upgrade. HPRA Ref: V50685


Philips Medical Systems
M5071A (adult) and M5072A (infant/child) pads for use with HS1/OnSite/Home AEDs
Advice regarding the use of the device. HPRA Ref: V50631


Randox Laboratories Ltd.
Randox Total Bile Acids
Advice regarding a device removal. HPRA Ref: V50536


Respironics California, LLC
V60/V60 Plus/V680 Ventilator
Advice regarding the use of the device. HPRA Ref: V50696


Siemens Healthcare Diagnostics Inc.
Atellica IM/ADVIA Centaur Enhanced Estradiol (eE2)
Advice regarding the use of the device. HPRA Ref: V50643


Stryker Endocscopy
1688 Camera Control Unit (CCU)
Advice regarding a software upgrade. HPRA Ref: V50480


Stryker Joint Replacement
Biolox Delta Ceramic V40 Femoral Head
Advice regarding a device removal. HPRA Ref: V50296


Z-Medica LLC 
QuikClot® Interventional Hemostatic Bandage™ CE – English, n/slit with 3M™ Tegaderm™ – Sterile Gauze Pad 1.5 IN x 1.5 IN (3.8CM x 3.8CM) and QuikClot® Interventional Hemostatic Bandage™ CE – English Language, pre-slit with 3M™ Tegaderm™ – Sterile Gauze Pad 1.5 IN x 1.5 IN (3.8CM x 3.8CM)
Advice regarding the use of the device. HPRA Ref: V50664
 

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