Summary of Field Safety Notices - June 2019

Notice type: 3rd Party Publications

Date: 01/07/2019

 

Further Information:
Abbott
Alinity ci-series System Control Module
Advice regarding a software upgrade. HPRA Ref: V40341

Aesculap AG
DISP.FLEECE DRAPE F/GA419/GD417 /GD421
Advice regarding a device removal. HPRA Ref: V40280

Antitoxin GmbH 
Human Monoclonal IgM Anti-C Blood Grouping Reagent, Clone: MS-273
Advice regarding the use of the device. HPRA Ref: V40122

Baxter
Prismaflex 7.XX Row, Prismaflex 8.XX Row, Prismaflex 6.10.XX Row, 
Advice regarding a software upgrade. HPRA Ref: V40107

Beckman Coulter
DxH800 and DxH600 and DxH 900 Hematology Analyzers 
Advice regarding the use of the device. HPRA Ref: V40182

Becton Dickinson Consumer Healthcare
BD Microtainer® Tubes
Advice regarding a device removal. HPRA Ref: V40270

Bio Rad
IH-QC1
Advice regarding changes/updates made to instructions for use. HPRA Ref: V39913

Covidien
Endo GIATM Surgical Stapling Single Use Loading Units, Tri-StapleTM 2.0 Intelligent Reloads and Cartridges
Advice regarding a device removal. HPRA Ref: V40103

Datascope Corp.
Sensation Plus 7.5Fr 40cc
Advice regarding a device removal. HPRA Ref: V40254

DiaMed GmbH
DiaClon Rh-Subgroups + K
Advice regarding the use of the device. HPRA Ref: V40355

ES-Medical AB
C-10 Probetester
Advice regarding the use of the device. HPRA Ref: V40219

Ethicon Endo-Surgery LLC.
Intraluminal Staplers (ILS)
Advice regarding a device removal. HPRA Ref: V39460

Fluoron GmbH
Brilliant Peel
Advice regarding a device removal. HPRA Ref: V40217

GBUK Healthcare
Nutricare Infant Clear Nasogastric Feeding Tube 6Fr 50cm Sterile
Advice regarding a device removal. HPRA Ref: V40552

GE Healthcare
Centricity Universal Viewer
Advice regarding a software upgrade. HPRA Ref: V40215

GE Healthcare
ECG trunk cables, ECG Leadwires
Advice regarding a device removal. HPRA Ref: V40566

GE Medical System (China) Co. Ltd
Achilles EXP II
Advice regarding a device modification. HPRA Ref: V39915

GE Medical System (China) Co. Ltd
Achilles EXP II
Advice regarding a software upgrade. HPRA Ref: V40222

Hologic Inc., USA 
Aptima Combo 2 for CT/NG Assay / APTIMA CT Assay
Advice regarding the use of the device. HPRA Ref: V39853

Leonhard Lang GmbH
Defibrillation Electrode SCHILLER - FSN
Defibrillation Electrode SCHILLER - Recall Letter
Advice regarding a device removal. HPRA Ref: V40306

Medical Intelligence Medizintechnik GmbH 
HexaPOD evo RT System
Advice regarding a software upgrade. HPRA Ref: V40525

Medtronic
Sherpa 6F Active Catheters
Advice regarding a device removal. HPRA Ref: V39302

Medtronic
Guardian Connect Application
Advice regarding the use of the device. HPRA Ref: V40173

Medtronic
MiniMed™ Paradigm™ Series and MiniMedTM 508 Insulin Pumps
Advice regarding the use of the device. HPRA Ref: V40568

Natus Medical Denmark T/A Otometrics
Chartr EP 200
Advice regarding the use of the device. HPRA Ref: V40391

NuVasive, Inc.
MAGEC® System
Advice regarding the use of the device. HPRA Ref: V40583

Pennine Healthcare
Pennine Intro-Uri-Cath
Advice regarding a device removal. HPRA Ref: V40227

Philips Healthcare 
BrightView, BrightView X, BrightView XCT
Advice regarding a device modification. HPRA Ref: V40330

Philips Medical Systems
HeartStart MRx Defibrillator/Monitor
Advice regarding the use of the device. HPRA Ref: V40239

QIAGEN GmbH
QIAsymphony Filter Tips, 1500µl (1024)
Advice regarding a device removal. HPRA Ref: V40246

Randox Laboratories Limited 
Assayed Bovine Multi-Sera-Level 1
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40304

Randox Laboratories Limited 
RX Daytona +, RX Imola
Advice regarding the use of the device. HPRA Ref: V40326

Roche Diabetes Care
Accu-Chek Insight
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40277

Siemens Healthcare GmbH
Artis zee and Artis Q
Advice regarding a device modification. HPRA Ref: V40380

Spectrum Medical Ltd. 
Quantum Pump Console
Advice regarding a software upgrade. HPRA Ref: V40383

Stanmore Implants Worldwide 
Femoral Heads with Incorrect Offset msfmh/cc28-3.5
Advice regarding a device removal. HPRA Ref: V38820

TaiDoc Technology Corporation
VTRUST TD-4258
Advice regarding a software upgrade. HPRA Ref: V40071

TEC COM GmbH
TECOtherm NEO - FSN
TECOtherm NEO - IFU
TECOtherm NEO - Updated FSN
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40204
 


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