My HPRA: Register

Summary of Field Safety Notices - December 2017

Notice type: 3rd Party Publications

Date: 03/01/2018

Further Information:
A&E Medical
A&E Medical Surgical Punch.
Advice regarding a device removal. HPRA Ref: V33697

Abbott
ARCHITECT c4000 Cuvette Segment, ARCHITECT c8000 Cuvette Segment, ARCHITECT c16000 Cuvette Segment
Advice regarding the use of the device. HPRA Ref: V34064

Abbott
ARCHITECT DHEA-S Reagents
Advice regarding the use of the device. HPRA Ref: V34148

Beckman Coulter
System Calibrator
Advice regarding a device modification. HPRA Ref: V33894

Biomerieux
ETEST®TP 256 (TEICOPLANIN)
Advice regarding a device modification. HPRA Ref: V34163

Biomet Orthopedics Switzerland GmbH
Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision
Advice regarding a device removal. HPRA Ref: V34125

Blatchford
KATO Plus Posture Belt & Posture Harness
Advice regarding the use of the device. HPRA Ref: V33884

Boston Scientific Corporation
Malecot Nephrostomy Catheter System, Malecot Nephrostomy Catheter Set, Re-Entry™ Malecot Nephrostomy Catheter Set, Percutaneous Access Set
Advice regarding a device removal. HPRA Ref: V33991

Boston Scientific Corporation
SpyScope™ DS SpyScope™ DS Access and Delivery Catheter
Advice regarding a device removal. HPRA Ref: V34160

Brainlab AG
Brainlab Navigation System Spine & Trauma 3D
Advice regarding a device removal. HPRA Ref: V33934

Cell Marque
Protease Digestive Enzyme
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V32837

Elekta
Integrity R1.2 and Integrity R3.2 Systems with a Precise Treatment Table
Advice regarding a software upgrade. HPRA Ref: V33723

Elekta
All digital accelerators with VI or iViewGT
Advice regarding a device modification. HPRA Ref: V33951

Fannin L.I.P.
W11159 Mueller Hinton + 5% Sheep Blood
Advice regarding a device removal. HPRA Ref: V34050

Greiner Bio-One
VACUETTE® FC Mix Tube 2ml and 3ml
Advice regarding changes/updates made to instructions for use. HPRA Ref: V34190

Iris-Beckman Coulter
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100
Advice regarding the use of the device. HPRA Ref: V33945

Johnson & Johnson Vision
ACUVUE® ADVANCE®, ACUVUE® OASYS® and 1-DAY ACUVUE® MOIST® for ASTIGMATISM
Advice regarding a device removal. HPRA Ref: V33686

Johnson & Johnson Vision
ACUVUE® OASYS® for ASTIGMATISM Brand Contact Lenses
Advice regarding a device removal. HPRA Ref: V33693

Kimal plc
Adult Altius Central Venous Catheter Kit (K2CS / K2CV) - 18G Echogenic Introducer Needle
Advice regarding a device removal. HPRA Ref: V33992

Maquet Cardiopulmonary
Heater Cooler 30, Heater Cooler 20
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33656

Medtronic
SynchroMed® II Implantable Drug Infusion Pump, models 8637-20 and 8637-40
Advice regarding a device removal. HPRA Ref: V33832

Medtronic
Signia Power Handle
Advice regarding a software upgrade. HPRA Ref: V34128

Novel Biocare
IPS CaseDesigner™ 1.3
Advice regarding a software upgrade. HPRA Ref: V34042

Performance Health
Patterson Walking Frames
Advice regarding the use of the device. HPRA Ref: V34088

Phadia AB
Phadia Prime
Advice regarding a software upgrade. HPRA Ref: V33899

Philips Volcano
Philips Volcano s5i, Core, and Core Mobile Systems with software version v3.5
Advice regarding a software upgrade. HPRA Ref: V33900

Physio-Control
Infant/Child Reduced Energy Defibrillation Electrodes
Advice regarding the use of the device. HPRA Ref: V33729

Radiometer
TCM5 FLEX/BASIC used with ECG and EEG monitor
Advice regarding the use of the device. HPRA Ref: V33532

Roche
Hematoxylin II and Horseradish Peroxidase reagents
Advice regarding the use of the device. HPRA Ref: V34208

Siemens Healthcare
Atellica UAS 800 Analyzer
Advice regarding a software upgrade. HPRA Ref: V34131

Siemens Healthcare
Atellica UAS 800 Analyzer
Advice regarding a software upgrade. HPRA Ref: V34132

Siemens Healthcare
Atellica UAS 800 Analyzer
Advice regarding a software upgrade. HPRA Ref: V34135

Siemens Healthcare GmbH
Somatom Definition AS, DS, Edge, Flash, Force
Advice regarding the use of the device. HPRA Ref: V33718

Smith & Nephew
TAYLOR SPATIAL FRAME™ WEBSITE SOFTWARE
Advice regarding the use of the device. HPRA Ref: V34159

Stryker
rHead® System Radial Head Arthroplasty / Uni Elbow
Advice regarding a device removal. HPRA Ref: V33602

Teleflex Malaysia
RUSCH Sensor (Series 400) Silicone
Rectal Pharyngeal Temperature Sensor, Non-Sterile
Advice regarding a device removal. HPRA Ref: V33880

ThermoFisher Scientific
ImmunoCAP™ Allergen c5, Ampicilloyl and ImmunoCAP™ Allergen c6, Amoxicilloyl
Advice regarding a device removal. HPRA Ref: V34146

Trumpf Medizin Systems
TruVidia™ Wireless Receiver
Advice regarding a device modification. HPRA Ref: V34081

Vascutek Limited
All Gelsoft, Gelsoft ERS, Gelsoft Plus, Gelsoft Plus ERS, Gelseal, Gelseal ERT, Gelweave, K-Thin, K-Thin ERS, and Gelseal Plus Vascular Prostheses. All Fluoropassiv, Fluoropassiv ER, Thin Wall Fluoropassiv and Thin Wall Fluoropassiv ER Vascular Prostheses. All Cariovascular Fabric Patches. All Seal PTFE and Taperflo Vascular Prostheses
Advice regarding the use of the device. HPRA Ref: V34012

Wright Medical
MoPyc Radial Head Prosthesis
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V30990

Zimmer Biomet
REVITAN® MODULAR RASP DISTAL CURVED
Advice regarding a device removal. HPRA Ref: V34122

Zimmer Inc
Various Hip and Knee Products FSN 1
Various Hip and Knee Products FSN 2
Advice regarding a device removal. HPRA Ref: V34139

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