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Summary of Field Safety Notices – January 2020
Notice type:
3rd Party Publications
Date:
03/02/2020
Further Information:
Summary of Field Safety Notices - January 2020
Abbott
HeartMate 3™ Modular Cables
Advice regarding the use of the device. HPRA Ref: V42322
HeartMate Mobile Power Unit™ and HeartMate 3TM Left Ventricular Assist System (LVAS) Kit
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42324
Alinity ci-series System Control Module - Version A
Advice regarding a software upgrade. HPRA Ref: V42770
Alinity ci-series System Control Module - Version B
Advice regarding a software upgrade. HPRA Ref: V42770
Abbott Vascular
NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters
Advice regarding a device removal. HPRA Ref: V42753
Arcroyal
Insufflation Tubing Set, with gas filter
Advice regarding a device removal. HPRA Ref: V42569
BAAT Medical Products B.V
Anterior Resection Plate
Advice regarding a device removal. HPRA Ref: V42589
Bard Limited
BARD Site~Rite 8 Ultrasound System
Advice regarding a software upgrade. HPRA Ref: V42591
Cardinal Health
Monoject™ 3mL Syringe with Hypodermic Safety Needle, Monoject™ Hypodermic Safety Needle, Monoject™ Bluntfill with Filter
Advice regarding a device removal. HPRA Ref: V42646
Surgical Gowns
Advice regarding a device removal. HPRA Ref: V42754
Chiesi Farmaceutici S.p.A.
LISACath - FSN 1
Advice regarding a device removal. HPRA Ref: V42762
LISACath - FSN 2
Advice regarding a device removal. HPRA Ref: V42762
Cook Medical
Zenith Alpha™ Spiral-Z® Endovascular Leg
Advice regarding the use of the device. HPRA Ref: V42639
Fast-Track Diagnostics S.a.r.l.
Various FTD products - Updated FSN
Advice regarding a device removal. HPRA Ref: V42435
FCI S.A.S.
Purified silicon oil reference S5.7570, S5.7170, S5.7560 et S5.7160
Advice regarding the use of the device. HPRA Ref: V42551
Full Support Healthcare
Easidrape
Advice regarding the use of the device. HPRA Ref: V42314
GE
ApexPro Telemetry System, CIC Pro Clinical Information Center Central Station and CARESCAPE Central Station Nomenclature text: Telemetry system, electrocardiograph and Patient monitor, central unit
Advice regarding the use of the device. HPRA Ref: V42769
GE Healthcare
Giraffe Blue Spot PT Lite Phototherapy Systems
Advice regarding a device modification. HPRA Ref: V42752
Getinge
Getinge 88-Series
Advice regarding a device modification. HPRA Ref: V42626
Hermann Bock GmbH
Practico Alu Plus
Advice regarding a device modification. HPRA Ref: V42381
Karl Storz
Insufflation Tubing Set, with gas filter
Advice regarding a device removal. HPRA Ref: V42510
Maquet SAS
Volista STANDOP, Volista TRIOP
Advice regarding a device modification. HPRA Ref: V39833
Medartis
2.5 Trilock Screw 14mm
Advice regarding a device removal. HPRA Ref: V42496
Medline
REU Plug Charger
Advice regarding a device removal. HPRA Ref: V42627
Medtronic
Polysorb and Biosyn Monofilament Absorbable suture
Advice regarding a device removal. HPRA Ref: V42405
Peters Surgical
Monopolar Scissors / Forceps / Hooks - English version
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42585
Monopolar Scissors / Forceps / Hooks - Irish version
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42585
Radiometer Medical Aps
ABL90 Flex / ABL90 Flex Plus
Advice regarding a software upgrade. HPRA Ref: V42657
ResMed Ltd
Stellar 100 and 150 Portable Ventilators
Advice regarding a software upgrade. HPRA Ref: V42384
Roche
Elecsys CA 19-9
Advice regarding the use of the device. HPRA Ref: V42751
Siemens Healthcare Diagnostics
Atellica IM 1300 and IM 1600 Analyzers
Advice regarding the use of the device. HPRA Ref: V42558
Immulite/Immulite 1000 Progesterone, Immulite 2000/Immulite 2000 XPi Progesterone - FSN 1
Advice regarding the use of the device. HPRA Ref: V40643
Immulite/Immulite 1000 Progesterone, Immulite 2000/Immulite 2000 XPi Progesterone - FSN 2
Advice regarding the use of the device. HPRA Ref: V40643
Atellica CH 930 Reaction Cuvette Segment
Advice regarding a device removal. HPRA Ref: V42624
SIEMENS Healthineers Systems
Software update for Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max
Advice regarding the use of the device. HPRA Ref: V42764
Smith & Nephew
PROFIX 750 Gr. Mallet
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42316
Stryker
LIFEPAK® 15 Monitor/Defibrillator
Advice regarding a device modification. HPRA Ref: V42615
Stryker Endoscopy, San Jose
Spy Phi Drapes
Advice regarding a device removal. HPRA Ref: V42717
Teleflex Medical
Arrow PICC, Epidural Catheter, Drape, Continuous Nerve Block Needle; CVC, PSI, Epidural Needle and Spinal Needle Kits
Advice regarding a device removal. HPRA Ref: V42550
Rusch Greenlite - MAC3 & MAC4
Advice regarding a device removal. HPRA Ref: V42592
Pilling Clear Advantage Disposable Aortic Punch
Advice regarding a device removal. HPRA Ref: V42665
Terumo BCT
Spectra Optia procedures with Correct Connect ACD-A Solution
Advice regarding the use of the device. HPRA Ref: V42353
W.L GORE and associates
Gore Excluder AAA Endoprosthesis & Gore IBE devices
Advice regarding the use of the device. HPRA Ref: V42493
Wright Medical
Aequalis Ascend Flex Humeral Stem
Advice regarding the use of the device. HPRA Ref: V42078
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Date Printed: 24/04/2024