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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
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Date Printed: 15/08/2022