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Field Safety Notice – September 2017
Notice type:
3rd Party Publications
Date:
03/10/2017
Further Information:
Applied Medical
5x55mm Kii Optical Z-Thread Dual Pack
Advice regarding a device removal. HPRA Ref: V33150
Beckman Coulter
Access BR Monitor
Advice regarding the use of the device. HPRA Ref: V31625
Biosense Webster Inc.
Thermocool SF NAV and Thermocool Smarttouch SF
Advice regarding a device removal. HPRA Ref: V33171
Boston Scientific
Model 3200 S-ICD Programmer
Advice regarding a software upgrade. HPRA Ref: V30497
Boston Scientific
Model 3200 S-ICD Programmer
Advice regarding a software upgrade. HPRA Ref: V32265
DePuy France SAS
Delta XTEND Reverse Shoulder System
Advice regarding a device removal. HPRA Ref: V33172
Elekta, Inc
ERGO®
Advice regarding the use of the device. HPRA Ref: V33267
Ethicon
VICRYL RAPIDE™ (Polyglactin 910) SUTURE
Advice regarding a device removal. HPRA Ref: V33094
Getinge
MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF
Advice regarding a device removal. HPRA Ref: V33345
HOYA Corporation
PENTAX Medical ED-3490TK Duodenoscope, all PENTAX Duodenoscopes
Advice regarding a device modification. HPRA Ref: V30627
HOYA Corporation
Pentax ultrasound Video Bronchoscope, EB-1970UK
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30629
KCI Medical
Revolve™ System
Advice regarding a device removal. HPRA Ref: V33210
McKesson Medical Imaging Company
McKesson Radiology Manager
Advice regarding a software upgrade. HPRA Ref: V32802
Medtronic
Medtronic MiniMed Infusion Sets
Advice regarding a device removal. HPRA Ref: V33136
Medtronic
GastriSail™ Gastric Positioning System
Advice regarding a device removal. HPRA Ref: V33252
Merit Medical
Peritoneal Dialysis Catheter
Advice regarding a device removal. HPRA Ref: V33227
Molnlycke
Molnlycke Procedure trays containing Maternity Pad
Advice regarding a device removal. HPRA Ref: V33303
Olympus
Cystoscopy Bridges and Working Inserts
Advice regarding a device removal. HPRA Ref: V33022
Radiometer Medical ApS
AUTOCHECK 5+ Level 2
Advice regarding a device removal. HPRA Ref: V33090
Randox
Lipid Control Level 3
Advice regarding a device modification. HPRA Ref: V32871
Siemens Healthcare
Artis systems with a wireless foot switch
Advice regarding a device modification. HPRA Ref: V33376
Smiths Medical ASD, Inc.
GrasebyTM 3300 Pump and Locking Accessories
Advice regarding a device removal. HPRA Ref: V33096
St Jude Medical
Infinity Deep Brain Stimulation (DBS) IPG devices
Advice regarding the use of the device. HPRA Ref: V33159
St Jude Medical
Proclaim Elite Spinal Cord Stimulation (SCS) IPG devices and Proclaim Dorsal Root Ganglion (DRG) IPG devices.
Advice regarding the use of the device. HPRA Ref: V33159
Synergy Health
Various sterile theatre products
Advice regarding a device removal. HPRA Ref: V33207
TEC COM GmbH
Temperature Probes for TECOTHERM NEO
Advice regarding the use of the device. HPRa Ref: V33114
ThermoFisher Scientific
Thermo Scientific™ RemelTM E. coli Polyvalent and Monovalent Agglutinating Sera
Advice regarding a device removal. HPRA Ref: V30456
Thermofisher Scientific Microbiology
ThermoScientific™ Oxoid™ CAZ10 Ceftazidime, CT1629B
Advice regarding a device removal. HPRA Ref: v33196
W.L. Gore and Associates, Inc.
Conformable GORE® TAG® Thoracic Endoprosthesis
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33443
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Date Printed: 20/04/2024