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Summary of Field Safety Notice – June 2017
Notice type:
3rd Party Publications
Date:
04/07/2017
Further Information:
Acandis GmbH & Co. KG
NeuroSpeed PTA Balloon Catheter
Advice regarding a device removal. HPRA Ref: V32197
AlterG, Inc
Anti-Gravity
Advice regarding a device modification. HPRA Ref: V32358
Angio Dynamics Inc.
Acculis Accu2i pMTA Applicator
Advice regarding a device removal. HPRA Ref: V32185
ArjoHuntleigh
FLOWTRON ACS900
Advice regarding a software upgrade. HPRA Ref: V32114
Atrium New Hampshire
Atrium Advanta V12 Balloon Expandable Covered Stent 7 mm x 22 mm x 120 cm
Advice regarding a device removal. HPRA Ref: V32123
Balt Extrusion
Microcatheter Sonic 1.5F
Advice regarding a device removal. HPRA Ref: V31807
Balt Extrusion
Microcatheter Sonic
Advice regarding the use of the device. HPRA Ref: V32278
Baxter
Claria Sharesource Platform
Advice regarding the use of the device. HPRA Ref: V32175
Baxter
AK 98, 230V, Bio
Advice regarding a device modification. HPRA Ref: V32209
Beckman Coulter
Synchron AQUA CAL Level 1
Advice regarding a device removal. HPRA Ref: V32070
Beckman Coulter
COULTER PrepPlus & PrepPlus 2
Advice regarding a device removal. HPRA Ref: V32111
Beckman Coulter
COULTER LH 750 Analyzer / COULTER LH 780 Analyzer / COULTER LH500 Analyzer / COULTER HmX CP Analyzer / COULTER HmX AL Analyzer
Advice regarding the use of the device. HPRA Ref: V32284
Beckman Coulter Ireland Inc.
DxH 500
Advice regarding a software upgrade. HPRA Ref: V31986
Biocompatibles UK Ltd. (BTG)
DC Bead™ and DC Bead M1™
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32213
Biomerieux
VITEK 2 Gram-Negative AST Cards
Advice regarding the use of the device. HPRA Ref: V32121
Boston Scientific
S-ICD Programmer
Advice regarding a software upgrade. HPRA Ref: V30497
Boston Scientific
S-ICD Memory Corruption - (S-ICD Systems: SQ-RX™ model 1010, EMBLEM™ model A209 and EMBLEM™ MRI model A219)
Advice regarding a software upgrade. HPRA Ref: V32265
CellaVision AB
DI-60
Advice regarding a software upgrade. HPRA Ref: V32359
Chalice Medical
Paratherm
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30535
Cook Medical
Vue Optic Visualization Source; Flexor Vue Deflecting Endoscopic System
Advice regarding the use of the device. HPRA Ref: V31755
Cook Medical
Zenith Alpha™ Thoracic Endovascular Graft
Advice regarding a device removal. HPRA Ref: V32326
Draeger Medical Systems Inc
Infinity Acute Care System (M540)
Advice regarding a device modification. HPRA Ref: V32108
Elekta
MOSAIQ
Advice regarding the use of the device. HPRA Ref: V32389
Endologix
AFX EndoVascular AAA System, with STRATA graft material
Advice regarding the review of patient results/patient recall/sample retesting isrequired. HPRA Ref: V32254
GE Healthcare
Infant Warmer System
Advice regarding a device modification. HPRA Ref: V32068
GE Healthcare
Centricity Critical Care (CCC, formerly known as Clinisoft)
Advice regarding a software upgrade. HPRA Ref: V32324
Hitachi High-Technologies Cooperation & Roche
PROBE SAMPLE - cobas c - FSN 1
PROBE SAMPLE - cobas c - Attachment 1
PROBE SAMPLE - cobas c - Attachment 2
PROBE SAMPLE - cobas c - Attachment 3
PROBE SAMPLE - cobas c - FSN 2
PROBE SAMPLE - cobas c - Attachment 4
Advice regarding a device removal. HPRA Ref: V31066
Hoya Corporation
Ultrasound Upper GI Videoscopes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32261
ICU Medical
Plum 360 Infusion Pump
Advice regarding a device modification. HPRA Ref: V32274
Intersurgical
BVM Manual Resuscitation Systems
Advice regarding the use of the device. HPRA Ref: V32113
Intuitive Surgical
da Vinci® Xi™ Surgical System
Advice regarding a device modification. HPRA Ref: V32145
Leica Biosystems
ASP6025 Tissue Processor
Advice regarding a device modification. HPRA Ref: V32151
LivaNova
Aortic Cannulae
Advice regarding a device removal. HPRA Ref: V32171
LivaNova
Model 105 Aspire HC® and 106 AspireSR® VNS Therapy® Generators
Advice regarding the use of the device. HPRA Ref: V32376
Maquet / Getinge
SoKinox/ServiNo
Advice regarding a software upgrade. HPRA Ref: V32397
Maquet / Getinge
Maquet/Datascope CS100i Intra-Aortic Balloon Pump (IABP); Maquet/Datascope CS100 Intra-Aortic Balloon Pump (IABP); Maquet/Datascope CS300 Intra-Aortic Balloon Pump (IABP)
Advice regarding a device modification. HPRA Ref: V32260
Medtronic Inc
11001G - DLP® Extension Line Adapters 20 in length; and various other devices
Advice regarding a device removal. HPRA Ref: V32323
NHSBT
Titration cell 1
Advice regarding a device removal. HPRA Ref: V32328
Philips
HeartStart MRx Monitor/Defibrillator
Advice regarding a device modification. HPRA Ref: V32172
Roche
Mixed sample results in immunochemistry modules
Advice regarding a software upgrade. HPRA ref: V32325
Sentinel Diagnostics
MULTIAGENT Creatinine (Enzymatic)
Advice regarding a device removal. HPRA Ref: V32039
Shimadzu
Rad Speed Series (Pro/CH-200/CH-200M)
Advice regarding a device modification. HPRA Ref: V31995
Siemens
Axiom Artis, Artis Zee, Q, and Q Zen systems.
Advice regarding a device modification. HPRA Ref: V32118
Siemens
Artis Systems, X-Workplace, Sensis and Arcadis Systems
Advice regarding a software upgrade. HPRA Ref: V32215
Siemens
Syngo Workflow MLR using Portal Radiologist
Advice regarding a software upgrade. HPRA Ref: V32384
Taizhou Xinkang Medical Material Co., Ltd
Wound dressing / NO.8, NO.9, NO.3
Advice regarding a device removal. HPRA Ref: V31604
Terumo Corporation
Radifocus Introducer II, Radifocus Introducer II M coat and Glidesheath Slender
Advice regarding a device removal. HPRA Ref: V32107
TOSHMedical
Aplio 500
Advice regarding a software upgrade. HPRA Ref: V32115
Trinity Biotech
Premier Buffer B Reagent
Advice regarding a device removal. HPRA Ref: V32110
UniSurge
Yellow Handled Sharp/Blunt Supasnip Scissors
Advice regarding a device removal. HPRA Ref: V31981
Wassenburg Medical B.V.
Wassenburg WD440 Endoscope Washer Disinfector
Advice regarding a software upgrade. HPRA Ref: V31054
Zimmer Biomet
Cementless Oxford Partial Knee Unicompartmental Knee Replacement System
Advice regarding the use of the device. HPRA Ref: V31252
Zimmer Biomet
Affixus Hip Fracture Nail
Advice regarding a device removal. HPRA Ref: V32144
Zimmer Biomet
Guidewire 70cm - FSN 1
Guidewire 70cm - FSN 2
Advice regarding a device removal. HPRA Ref: V32262
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Date Printed: 27/07/2024