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Summary of Field Safety Notices - December 2019
Notice type:
3rd Party Publications
Date:
07/01/2020
Further Information:
Summary of Field Safety Notices - December 2019
3M Deutschland GmbH
3M™ Durapore™ Advanced Surgical Tape
Advice regarding a device removal. HPRA Ref: V42336
Applied Medical
Python® Catheters, BARD Latex-free Arterial Embolectomy Catheters, and Over-the-Wire latis® Graft Cleaning Catheters
Advice regarding a device removal. HPRA Ref: V42221
Avanos
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit
Advice regarding a device removal. HPRA Ref: V41929
BD
T34™ Syringe Pump, 3rd Edition
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42437
Bedfont
V42422_FSN
Advice regarding a device removal. HPRA Ref: V42422
bioMérieux UK
Vidas VSG
Advice regarding a device removal. HPRA Ref: V42354
Coris BioConcept
Crypto-Strip
Advice regarding a device removal. HPRA Ref: V42426
Datex-Ohmeda Inc.
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation and Giraffe OmniBed Carestation - FSN 1
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42507
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation and Giraffe OmniBed Carestation - FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42507
Dexcom
Dexcom G6 iOS CGM App
Advice regarding a software upgrade. HPRA Ref: V42260
DiaSource
17OHP RIA
Advice regarding a device removal. HPRA Ref: V42026
Edwards Lifesciences
QuickDraw Venous Cannula (QD22 and QD25)
Advice regarding the use of the device. HPRA Ref: V42339
Edwards Lifesciences LLC
HemoSphere Oximetry Cable
Advice regarding a device removal. HPRA Ref: V42223
Elekta
Flexitron
Advice regarding the use of the device. HPRA Ref: V42181
Fast-Track Diagnostics S.a.r.l.
Various FTD products
Advice regarding a device removal. HPRA Ref: V42435
Foundation Medicine Inc.
Cell-Free DNA Collection Tube 2 Pack 16 x 100 mm
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42380
Ge Healthcare
Centricity Universal Viewer 6.0 software
Advice regarding a software upgrade. HPRA Ref: V42515
Intuitive Surgical
Endoscope and Camera Head Sterilization Tray
Advice regarding the use of the device. HPRA Ref: V42478
Johnson & Johnson - AMO Uppsala
Healon GV® PRO
Advice regarding a device removal. HPRA Ref: V42310
Karl Storz
Autocon
Advice regarding a software upgrade. HPRA Ref: V42473
Mediplus Ltd.
5822, Pump tube set for MMSLibra, Libraplus & Solar urodynamics system
Advice regarding a device removal. HPRA Ref: V41996
Medline
Charger Base UK Plug
Advice regarding a device removal. HPRA Ref: V42146
MicroVention
Azur Peripheral Coil System
Advice regarding the use of the device. HPRA Ref: V42317
MicroVention
MicroPlex and HydroCoil Embolic System
Advice regarding a device removal. HPRA Ref: V42340
Nal von minden GmbH
NADAL hCG Pregnancy Test
Advice regarding the use of the device. HPRA Ref: V42332
Philips Healthcare UK
VesselNavigator application in combination with Azurion R1.2.x and R2.0.x
Advice regarding a software upgrade. HPRA Ref: V42421
Philips Medical Systems Nederland BV
Velara X-ray generator
Advice regarding a device modification. HPRA Ref: V42512
Roche - FSN Version 2
ALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3) - Version 2
Advice regarding a device removal. HPRA Ref: V41233
Schiller Medical S.A.S
DE FIGARO Touch 7
Advice regarding a software upgrade. HPRA Ref: V42470
Siemens Healthcare Diagnostics Inc
Atellica CH 930 Analyzer
Advice regarding the use of the device. HPRA Ref: V41728
Siemens Healthcare Diagnostics Inc
Atellica and ADVIA hsCRP Calibrator - FSN 1
Advice regarding the use of the device. HPRA Ref: V42174
Atellica and ADVIA hsCRP Calibrator - FSN 2
Advice regarding the use of the device. HPRA Ref: V42174
Enzymatic Creatinine Rgt - FSN 1
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42457
Enzymatic Creatinine Rgt - FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42457
Enzymatic Creatinine Rgt - FSN 3
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42457
Enzymatic Creatinine Rgt - FSN 4
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42457
VitreQ
VitreQ Vitrectomy fluid/gas handling Instrument / VitreQ Ophthalmic infusion/aspiration cannula, single-use
Advice regarding a device removal. HPRA Ref: V42456
Willy Rüsch GmbH
Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery
Advice regarding a device removal. HPRA Ref: V39698
Zimmer Biomet
Orthopedic cement, medicated - To Distributors
Advice regarding the use of the device. HPRA Ref: V42417
Orthopedic cement, medicated - To Surgeons
Advice regarding the use of the device. HPRA Ref: V42417
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Date Printed: 20/04/2024