My HPRA: Register

Summary of Field Safety Notices - October 2016

Notice type: 3rd Party Publications

Date: 02/11/2016

  

Further Information:
Abbott Laboratories
ARCHITECT Lactic Acid
Advice regarding the use of the device. HPRA Ref: V29605



ArcRoyal
ArcRoyal custom trays - Devon™ Light Gloves/Medtronic
Advice regarding the use of the device. HPRA Ref: V29783



Aspen Medical
Sorbsan Calcium Alginate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Calcium Alginate Dressing (Flat)
Advice regarding a device removal. HPRA Ref: V28128



B. Braun
Dialog+ SW 8.2A with option Adimea
Advice regarding a software upgrade. HPRA Ref: V29596



Bausch & Lomb Incorporated - USA
LazerEdge Knifes. FSN 1
LazerEdge Knifes. FSN 2
Advice regarding a device removal. HPRA Ref: V29624



Baxter
AK 98, 230V Bio
Advice regarding a software upgrade. HPRA Ref: V29781



Baylis Medical
NRG Transseptal Needle
Advice regarding a device removal. HPRA Ref: V29722



Covidien 
Clearify Visualization System
Advice regarding a device removal. HPRA Ref: V29523



Covidien 
Custom Procedure kits containing certain production lots of Clearify™ Visualization System
Advice regarding a device removal. HPRA Ref: V29639



Covidien LLC - Mansfield (Medtronic)
Devon™ Light Glove
Advice regarding the use of the device. HPRA Ref: V29408



DePuy Synthes
SynReam Reaming Rod 2.5mm, L 650mm sterile
Advice regarding a device removal. HPRA Ref: V29645



Gabmed GmbH
gabControl D-Dimer rapid test
Advice regarding a device removal. HPRA Ref: V29644



GE Medical Systems Information Technologies Inc.
MAC 600, MAC 800, MAC 1200, MAC 1600, MAC 2000, MAC 3500, MAC 5000, MAC 5500, MAC 5500 HD
Advice regarding the use of the device. HPRA Ref: V29466



GE Medical Systems SCS
Innova x100
Advice regarding a device modification. HPRA Ref: V29766

  

Getinge Lancer
GETINGE ED-FLOW AER, ED-FLOW SD AER
Advice regarding a software upgrade. HPRA Ref: V29318



Laerdal
Laerdal Suction Unit - July 2016 FSN
Laerdal Suction Unit - September 2016 FSN
Advice regarding a device modification. HPRA Ref: V29583


  
Leonhard Lang GmbH
Defibrillation electrode SCHILLER DF87C and DF56C
Advice regarding the use of the device. HPRA Ref: V29782



Medela AG
UK (Type G) detachable power plugs for certain Medela breast pumps
Advice regarding a device removal. HPRA Ref: V29397



Medtronic
Medtronic Model 37751 Recharger included in Model 37651, 37754 and 97754 Charging System. FSN 1
Medtronic Model 37751 Recharger included in Model 37651, 37754 and 97754 Charging System. FSN 2
Advice regarding the use of the device. HPRA Ref: V29659



Medtronic
Pipeline Embolization Device™ (Pipeline Classic), Alligator Retrieval Device™, Xcelerator™ Hydrophilic Guidewire, UltraFlow™ HPC Flow Directed Microcatheter, Marathon Flow Directed Microcatheter™
Advice regarding a device removal. HPRA Ref: V29532



Medtronic
SynchroMed® II Implantable Drug Infusion Pump
Advice regarding the use of the device. HPRA Ref: V29720



One Lambda Inc.
LABType DNA Typing Tests
Advice regarding the use of the device. HPRA Ref: V29682



Össur
Thermobrace / Assist 8 Extra / Duo Standard Belt / Dual Maternity Belt / Double Shoulder Brace / Wrist/thumb brace elastic / Velastic Plus / Wrist/thumb brace neoprene / Wrist/thumb wrap abducted / Elastic Thumb Spica / Simpla Wrist Brace / Thermowrap knee sleeves/wraps / Temp hernia Support (Custom only) / Fabric Hip Spica / Thomas Splint Traction Kit (Adult & Paediatric Adhesive)
Advice regarding the use of the device. HPRA Ref: V27218



Philips Medical Systems (Cleveland) Inc
Brilliance iCT / Brilliance iCT SP / Brilliance Big Bore / Brilliance 64/Brilliance 40 / Brilliance 16 / Brilliance 6 / Brilliance 10 / Brilliance 16P/Ingenuity CT / Ingenuity Core / Ingenuity Core128
Advice regarding a software upgrade. HPRA Ref: V29790



RBC Bioscience
MagCore® Viral Nucleic Acid Extraction Kits
Advice regarding changes/updates made to instructions for use. HPRA Ref: V28687



Roche
GLU/LAC/UREA(BUN) Cassette
Advice regarding a software upgrade. HPRA Ref: V29652



SCIEX
MultiQuantTM MD software - Version 3.0, 3.0.1 and 3.0.2. Component of the API 3200MDTM LC/MS/MS system, 3200MD QTRAP® LC/MS/MS system, Triple QuadTM 4500MD LC/MS/MS system, and QTRAP® 4500MD LC/MS/MS system
Advice regarding a software upgrade. HPRA Ref: V28283



Siemens Healthcare GmbH
SOMATOM Definition AS, SOMATOM Definition Flash
Advice regarding the use of the device. HPRA Ref: V29713



St. Jude Medical 
Fortify™, Fortify Assura™, Quadra Assura™, Unify™, Unify Assura™ and Unify Quadra™ ICD. FSN 1
Fortify™, Fortify Assura™, Quadra Assura™, Unify™, Unify Assura™ and Unify Quadra™ ICD. FSN 2
Advice regarding a device removal. HPRA Ref: V29552



Stryker
Trident Universal Impactor / Positioner
Advice regarding the use of the device. HPRA Ref: V29091



Stryker
LFIT™ Anatomic CoCr V40™ Femoral Heads
Advice regarding the use of the device. HPRA Ref: V29355



Teleflex Medical
Mucosal Atomization Device (MAD)
Advice regarding a device removal. HPRA Ref: V29751



Teleflex Medical
Mucosal Atomization Device (MAD), FlexiNozzle, Laryngo-Tracheal MAD, MADgic, Endotracheal MAD, MADett
Advice regarding a device removal. HPRA Ref: V29753



Trinity Biotech
MicroTrak® RPR Syphilis products
Advice regarding a device removal. HPRA Ref: V29662



Vascular Solutions Inc. 
Twin-Pass (5200), Twin-Pass RX (5210) and Twin-Pass .023” (5230)
Advice regarding a device removal. HPRA Ref: V29297



Vygon
Nutrisafe2
Advice regarding a device removal. HPRA Ref: V26514



Zimmer Biomet
Java Pedicle Screw System Instruments and containers, 
Fidji Cervical Cage Instruments and containers,
Fidji Lumbar Cage Instruments and containers,
Wallis Posterior Dynamic Stabilization System instruments and containers."
Advice regarding changes/updates made to instructions for use. HPRA Ref: V29709

« Back