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Summary of Field Safety Notices - December 2021
Notice type:
3rd Party Publications
Date:
04/01/2022
Further Information:
Summary of Field Safety Notices - December 2021
Abbott Molecular, Inc.
Alinity m System
Advice regarding a device modification. HPRA Ref: V48246
Alinity m System
Advice regarding a device modification. HPRA Ref: V48247
Alinity m System
Advice regarding a device modification. HPRA Ref: V48260
Abbott Point of Care
i-STAT CG8+ and EG7+ Cartridges - Updated FSN
Advice regarding the use of the device. HPRA Ref: V46746
Avanos Medical
Avanos Micbol Gastro Tube 12FR ENFIT, Avanos Micbol Gastro Tube 14FR ENFIT, Avanos Micbol Gastro Tube 16FR ENFIT, Avanos CRSCP NJ Tube 12FR 152CM WGT ENFIT
Advice regarding the use of the device. HPRA Ref: V47631
Batec Mobility S.L
Wheelchair electric-motor-driven propulsion system
Advice regarding a device modification. HPRA Ref: V48214
Boston Scientific
Jagtome™ RX, Hydratome™ RX, Dreamtome™ RX, Cannulating Sphincterotomes, and Jagtome™ Revolution RX
Advice regarding a device removal. HPRA Ref: V48290
CooperVision
Lens Care Solution / Saline Bottles: Hy-Care, All in One Light,Refine One Step Peroxide, Preservative Free Saline
Advice regarding a device removal. HPRA Ref: V48457
D.O.R.C.
EFTIAR Octane, syringes and vial, 5ml and 7ml
Advice regarding changes/updates made to instructions for use. HPRA Ref: V48417
Depuy
Global Unite Stem
Advice regarding a device removal. HPRA Ref: V48206
Drägerwerk AG
Perseus A500 Ceiling Version
Advice regarding a device modification. HPRA Ref: V48262
GC Tech Europe GmbH
Aadva Twist Drill (within Aadva Surgical kit)
Advice regarding a device removal. HPRA Ref: V48201
Hain Lifescience GmbH
GenoType MTBDRplus V. 2.0 / GenoType MTBDRsl V.2.0
Advice regarding the use of the device. HPRA Ref: V47929
Hillrom
Liko M220 / Liko M230
Advice regarding the use of the device. HPRA Ref: V48395
Immucor GTI Diagnostics, Inc
MATCH IT! Platelet Antibody Software
Advice regarding the use of the device. HPRA Ref: V48231
Intelerad Medical Systems Incorporated
IntelePACS
Advice regarding a software upgrade. HPRA Ref: V48390
Maillefer Instruments Holding SARL
Pathfile, Proglider, Protaper Gold
Advice regarding a device removal. HPRA Ref: V48371
Medline Industries, LP
Soft suction liner - suction system canister liner
Advice regarding the use of the device. HPRA Ref: V48221
Ortho Clinical Diagnostics
ORTHO VISION and ORTHO VISION Max Analyzers
Advice regarding the use of the device. HPRA Ref: V48194
Roche Diagnostics
Elecsys CA 19-9 - FSN V8
Advice regarding the use of the device. HPRA Ref: V42751
Vigmed (Greiner Bio-One GmbH)
CLiP Ported
Advice regarding a device removal. HPRA Ref: V48188
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Date Printed: 25/04/2024