My HPRA: Register

Summary of Field Safety Notices - May 2017

Notice type: 3rd Party Publications

Date: 01/06/2017

  

Further Information:
ArcRoyal
Inflation Device 30 atm
Advice regarding a device removal. HPRA Ref: V31800


B & D Electromedical
NIPPY 3+, NIPPY Junior+, NIPPY ST+ and NIPPY S+ ventilators
Advice regarding a device modification. HPRA Ref: V32007

  
Beckman Coulter
UniCel DxH 800/600 Coulter Cellular Analysis System
Advice regarding the use of the device. HPRA Ref: V31758


Beckman Coulter
Access Total T3, Thyroglobulin, Free T4 & GI Monitor Assays
Advice regarding changes/updates made to instructions for use. HPRA Ref: V31856


Cook Medical
OptiLite Multi-Use Holmium Laser Fibers
Advice regarding a device removal. HPRA Ref: V31682


Covidien (Medtronic)
Polysorb™, Endo Stitch™ Loading Unit with Polysorb™, Maxon™, Biosyn™ Absorbable Sutures
Advice regarding a device removal. HPRA Ref: V31746


Covidien LLC
Endo Peanut Auto Suture Blunt Dissector 5mm
Advice regarding a device removal. HPRA Ref: V31808


Diamed GmbH
ID-Diacells
Advice regarding the use of the device. HPRA Ref: V30834


Elekta
HexaPOD evo RT System / Medical Intelligence Mediz
Advice regarding a software upgrade. HPRA Ref: V31968


Fannin
Columbia Blood Agar + Neomycin
Advice regarding a device removal. HPRA Ref: V31750


GE / Datex-Ohmeda
Carestation 620, 650 and 650c
Advice regarding a device modification. HPRA Ref: V31894


IBL International GmbH
Parathyroid hormone intact ELISA
Advice regarding a device removal. HPRA Ref: V30252


KLS Martin
Ixos® P4 Wave radius plate system
Advice regarding a device removal. HPRA Ref: V31964


Leica Microsystems AG
M525 F40 Surgical Microscopes
Advice regarding the use of the device. HPRA Ref: V31882


LivaNova / Sorin Group Deutschland GmbH
Heater-cooler (1T), Heater-cooler 3T, FlexTherm
Advice regarding a device modification. HPRA Ref: V31769

  
Medtronic
MiniMed 640G Insulin Pump. FSN 1
MiniMed 640G Insulin Pump. FSN 2
Advice regarding the use of the device. HPRA Ref: V31974


Medtronic Navigation Inc
NavLock Tracker
Advice regarding the use of the device. HPRA Ref: V31896


Merck- Millipore
Bioscot Anti-M Monoclonal Murine IgG Blood Grouping Reagent
Advice regarding a device removal. HPRA Ref: V31924


Millipore UK Limited
BIOSCOT Monoclonal Control Reagent
Advice regarding a device modification. HPRA Ref: V31716


Molnlycke
Brennen® Skin Graft Mesher. FSN 1
Brennen® Skin Graft Mesher. FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V31698


Molnlycke
Barrier® Sets
Advice regarding a device removal. HPRA Ref: V31753


Orthpediatrics, Corp.
Orthopaedic Bone Screw, Non-Biodegradable
Advice regarding a device removal. HPRA Ref: V31927


Philips
V60 Ventilators, manufactured before 15 September 2015
Advice regarding a device modification. HPRA Ref: V31847

  
Philips
IntelliVue Neuromuscular Transmission Patient Cable
Advice regarding a device removal. HPRA Ref: V31918


Philips Medical Systems
DigitalDiagnost
Advice regarding a software upgrade. HPRA Ref: V31915


Quotient
ALBAclone® Advanced Partial RhD Typing Kit
Advice regarding a device removal. HPRA Ref: V31781


Randox
Liquid Cardiac Control
Advice regarding changes/updates made to instructions for use. HPRA Ref: V31782


Siemens
N Protein Standard SL and N/T Protein Control SL
Advice regarding changes/updates made to instructions for use. HPRA Ref: V31890


Siemens
RAPIDLab 348 Gas cartridge pack
Advice regarding the use of the device. HPRA Ref: V31880


Teleflex Medical
Sheridan SHER-I-SLIP ® and SOFT-TIP Intubating Stylets
Advice regarding a device removal. HPRA Ref: V31853


Thermofisher Scientific
Various Microgenics Application Sheets
Advice regarding a device removal. HPRA Ref: V31893


Vascular Solutions
Venture Catheters
Advice regarding a device removal. HPRA Ref: V31764

« Back