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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