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Summary of Field Safety Notices - September 2019
Notice type:
3rd Party Publications
Date:
01/10/2019
Further Information:
Abbott
Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module
Advice regarding a software upgrade. HPRA Ref: V41446
Abbott
03R65-01: Alinity i Processing Module 03R67-01: Alinity c Processing Module
Advice regarding a device modification. HPRA Ref: V41478
Apollo Endosurgery
Orbera365 Intragastric Balloon System / BIB Intragastric Balloon System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40836
ArcRoyal
Sterile Absorbent Cotton O.R. Towels
Advice regarding the use of the device. HPRA Ref: V41448
Beckman Coulter Inc
Enzymatic Creatinine Reagent, Triglycerides GPO Blanked Reagent, Uric Acid Reagent, Direct bilirubin Reagent, Total bilirubin Reagent
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41344
Bio-Rad
DC-Screening II
Advice regarding a device removal. HPRA Ref: V41432
Boston Scientific Limited
EMBLEM S-ICD and EMBLEM MRI S-ICD - FSN 1
Advice regarding the use of the device. HPRA Ref: V41307
Boston Scientific Limited
EMBLEM S-ICD and EMBLEM MRI S-ICD - FSN 2
Advice regarding the use of the device. HPRA Ref: V41307
Candela
GentleCool Pro Cryogen Canister
Advice regarding a device removal. HPRA V41447
COOPERSURGICAL
'COOPERSURGICAL EMBRYOLOGY HEATED PLATE WITHIN THE RI WITNESSTM
Advice regarding a device modification. HPRA Ref: V41495
Elekta, Inc.
MOSAIQ
Advice regarding a software upgrade. V41558
GE Healthcare
Giraffe Warmer / Panda iRes Warmer
Advice regarding changes/updates made to instructions for use. V41304
GE Healthcare
Aespire 7100, Aestiva 7900/MRI/7100/100
Advice regarding the use of the device. V41374
Gentherm Medical
Norm-0-Temp Hyperthermia System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41170
Gentherm Medical
Blanketrol III
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41411
HemoCue AB
HemoCue Glucose 201 DM RT Analyzer
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41371
Johnson & Johnson Vision Care Inc.
Y ACUVUE® MOIST®for ASTIGMATISM Contact Lenses
Advice regarding a device removal. HPRA Ref: V41353
Leonhard Lang GmbH
Defibrillation electrode Mindray MR62
Advice regarding a device removal. HPRA Ref: V40090
LivaNova
Model 1000 SenTiva® VNS Therapy® Generators (S/N < 100000)
Advice regarding a device removal. HPRA Ref: V40172
LivaNova
VNS Therapy SenTiva Generator - FSN 1
Advice regarding a device removal. HPRA Ref: V41574
LivaNova
VNS Therapy SenTiva Generator - FSN 2
Advice regarding a device removal. HPRA Ref: V41574
LivaNova
VNS Therapy SenTiva Generator - Attachment 1
Advice regarding a device removal. HPRA Ref: V41574
Maquet Cardiopulmonary GmbH
VHK and VKMO(D) Adult/Small Adult Accessories
Advice regarding a device removal. HPRA Ref: V41406
Maquet Cardiopulmonary GmbH
VHK and VKMO(D) Adult/Small Adult Accessories- Attachment 1
Advice regarding a device removal. HPRA Ref: V41406
Maquet Cardiopulmonary GmbH
VHK and VKMO Adult / Small Adult
Advice regarding a device removal. HPRA Ref: V41442
Maquet Cardiopulmonary GmbH - Annex 1
VHK and VKMO Adult / Small Adult
Advice regarding a device removal. HPRA Ref: V41442
Medline
Sterile OR Towel
Advice regarding a device removal. HPRA Ref: V41156
Medtronic
Euphora™ and Solarice™ Semi-Compliant Rapid Exchange Balloon Dilatation Catheters
Advice regarding a device removal. HPRA Ref: V41349
Pall Medical, A Division of Pall International Sarl
Ultipor 25 / Breathing System Filter
Advice regarding a device removal. HPRA Ref: V38744
Philips Healthcare
Efficia DFM100
Advice regarding a software upgrade. HPRA Ref: V41151
Philips Healthcare
S7-3t & S8-3t Transesophageal (TEE) Transducers
Advice regarding a device removal. HPRA Ref: V41329
Randox Laboratories Limited
Rheumatoid Factor Standard, Liquid Protein Calibrators
Advice regarding a device modification. HPRA Ref: V41369
Roche
ALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3)
Advice regarding the use of the device. HPRA Ref: V41233
Roche
ALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3) - FSN Acknowledgement Form
Advice regarding the use of the device. HPRA Ref: V41233
Rocket Medical Plc
Fetal Blood Sampling Kit
Advice regarding the use of the device. HPRA Ref: V41088
Siemens Healthcare Diagnostics INC
Atellica CH 930 Analyzer
Advice regarding a software upgrade. HPRA Ref: V41470
Siemens Healthcare GmbH
Artis zee and Artis Q systems
Advice regarding a device modification. HPRA Ref: V40380
W.O.M World of Medicine
Aquilex Fluid Control System (AQL-100CBS)
Advice regarding a device removal. HPRA Ref: V41436
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Date Printed: 27/07/2024