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Summary of Field Safety Notices - September 2018
Notice type:
3rd Party Publications
Date:
01/10/2018
Further Information:
Abbott
Accelerator APS -FSN 1
Accelerator APS - Attachment
Advice regarding a device modification. HPRA Ref: V37226
Abbott (Wiesbaden)
Alinity i Processing Module
Advice regarding a device modification. HPRA Ref: V37337
Abbott GmbH
Alinity s System
Advice regarding a software upgrade. HPRA Ref: V37054
Abbott GmbH
CentriMag™ Acute Circulatory Support System Motor Model: 201-10002
Advice regarding the use of the device. HPRA Ref: V37231
ACUTRONIC Medical Systems AG
fabian Therapy evolution
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36741
Alcon Laboratories Inc.
Alcon CyPass® Micro-Stent
Advice regarding a device removal. HPRA Ref: V37010
Alere
Alere Triage® NT-pro BNP Test
Advice regarding the use of the device. HPRA Ref: V37114
Axis-Shield Diagnostics Ltd
Alere NT-proBNP for ARCHITECT Controls
Advice regarding a device removal. HPRA Ref: V37284
B. Braun Medical Limited
220-240V Unit Cable (power cord) for Infusomat fmS, Infusomat P and SpaceCover
Advice regarding a device removal. HPRA Ref: V37283
Bauch& Lomb INC
Stellaris Elite Single Port Vitrectomy Cutters
Advice regarding a device removal. HPRA Ref: V36715
Baxter
AK 98
Advice regarding the use of the device. HPRA Ref: V37278
Beckman Coulter Ireland Inc
Lipase OSR6x30, Uric Acid OSR6x98, HDL-Cholesterol OSR6x87, Enzymatic Creatinine OSR6x204
Advice regarding a device modification. HPRA Ref: V36847
Beekley Corporation
S-SPOT, TomoSPOT, O-SPOT
Advice regarding a device removal. HPRA Ref: V36912
BioFire Diagnostics
BioFire® FilmArray® Blood Culture Identification Panel
Advice regarding the use of the device. HPRA Ref: V37232
Caesare Medical Electronics Limited
T34 Ambulatory Syringe Pump
Advice regarding the use of the device. HPRA Ref: V35346
Cardiac Pacemaker Inc – A wholly owned subsidiary of Guidant Corporation – A wholly owned subsidiary of Boston Scientific Corporation
ACCOLADE™ & ACCOLADE™ MRI, PROPONENT™ & PROPONENT™ MRI, ESSENTIO™ & ESSENTIO™ MRI, VISIONIST™ X4 & VALITUDE™ X4 - FSN 1
ACCOLADE™ & ACCOLADE™ MRI, PROPONENT™ & PROPONENT™ MRI, ESSENTIO™ & ESSENTIO™ MRI, VISIONIST™ X4 & VALITUDE™ X4 - FSN 2
Advice regarding the use of the device. HPRA Ref: V37235
CooperSurgical Inc
Lone Star Single-Use Elastic Stays
Advice regarding a device removal. HPRA Ref: V37298
Covidien LLC
Puritan Bennett™ 980 (PB980) ventilator series
Advice regarding a software upgrade. HPRA Ref: V37345
Dr. Mach GmbH & Co. KG
Dr. Mach OT Light with Heavy Central Axis
Advice regarding the use of the device. HPRA Ref: V36699
Endologix International Holdings B.V.
AFX EndoVascular AAA System
Advice regarding the use of the device. HPRA Ref: V37351
Harvest Healthcare Ltd.
HA200 Unipump - Opal, Opal Plus, Salisbury and Prime Overlay Mattresses and HH20 Active Seat System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V34743
Intuitive Surgical Inc
da Vinci® EndoWrist® Monopolar Curved Scissors
Advice regarding the use of the device. HPRA Ref: V36898
IVT Imuno, s.r.o.
AB0 bedside kit
Advice regarding the use of the device. HPRA Ref: V36232
Leica Biosystems
Slide Labeler (Zebra) used with BOND-MAX/BOND-III
Advice regarding the use of the device. HPRA Ref: V37180
Leica Microsystems
Leica M525 F20
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36911
Maquet Critical Care AB
SoKINOX/SERViNO NO Delivery and Monitoring System
Advice regarding a software upgrade. HPRA Ref: V37264
Mast Group Ltd.
AUGMENTIN 32mg/L PLATE, MPM-AUG32
Advice regarding a device modification. HPRA Ref: V36073
medica Medizintechnik GmbH
THERA-Trainer balo /THERA-Trainer verto
Advice regarding a device modification. HPRA Ref: V36701
Oridion Medical 1987 Ltd.
Capnostream™ 20 and Capnostream™ 20p Bedside Patient Monitors
Advice regarding a software upgrade. HPRA Ref: V36804
Orthofix SRL
Drill Bits
Advice regarding a device removal. HPRA Ref: V37406
Ovesco Endoscopy
AWC-Additional Working Channel
Advice regarding a device removal. HPRA Ref: V37107
Randox Laboratories Limited
Liquid Cardiac Control - FSN
Liquid Cardiac Control - Attachment
Advice regarding changes/updates made to instructions for use. HPRA Ref: V37379
Roche
Accu-Chek Inform II, cobas h 232, CoaguChek Pro II, CoaguChek XS Plus / XS Pro systems
Advice regarding a software upgrade. HPRA Ref: V36909
Roche Diagnostics GmBH
MagNA Pure 24 System
Advice regarding a software upgrade. HPRA Ref: V35702
Roche Diagnostics GmBH
Elecsys FT4 III
Advice regarding the use of the device. HPRA Ref: V37320
SEERS Medical Ltd.
SEERS Medical Bariatric Drop End Couches
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36951
Stryker
XIA 3 Degen Tray / XIA 3 Rod and Cross Connector Tray / French Bender
Advice regarding the use of the device. HPRA Ref: V37191
Stryker Leibinger GmbH&Co KG
HydroSet Injectable HA Bone Substitute
Advice regarding a device removal. HPRA Ref: V37276
Stryker Medical
Altrix model 8001
Advice regarding a device removal. HPRA Ref: V37395
Varian Medical Systems
TrueBeam, TrueBeam STx, VitalBeam and EDGE treatment delivery systems
Advice regarding a software upgrade. HPRA Ref: V36874
Welch Allyn Inc
Connex Spot Monitor (CSM) with Masimo SpO2 option
Advice regarding a software upgrade. HPRA Ref: V36322
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Date Printed: 25/04/2024