My HPRA: Register

Summary of Field Safety Notice – March 2016

Notice type: 3rd Party Publications

Date: 04/04/2016

  

Further Information:
Abbott Ireland Diagnostics Division
ARCHITECT Estradiol Reagent, list number (LN) 7K72
Advice regarding the use of the device: HPRA Ref: V26950

Abbott Laboratories
CELL-DYN Emerald Cleaner
Advice regarding a device removal: HPRA Ref: V27331

Arrow International Inc.
ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
Advice regarding a device removal: HPRA Ref: V26934

B&D Electromedical
NIPPY 3+, NIPPY JUNIOR+, NIPPY ST+, and NIPPY S + ventilators
Advice regarding the use of the device: HPRA Ref: V27100

B. Braun Avitum 
Dialog+ SW 9.xx Double Pump Machines HDF-Online
Advice regarding a device modification: HPRA Ref: V27261

Biosensors Europe SA
BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stent System (DES)
Advice regarding a device removal: HPRA Ref: V27022

Datex Ohmeda Inc. (GE Healthcare)
Aisys CS2
Advice regarding a device modification: HPRA Ref: V27350

Dexcom Inc.
G4 Platinum and GS Mobile receiver
Advice regarding the use of the device: HPRA Ref: V26993

DiaSys Diagnostic Systems GmbH
TruLab N+P, TruLab Protein, TruLab Urine, TruCal U
Advice regarding the use of the device: HPRA Ref: V27074

Focus Diagnostics
Simplexa CMV and Simplexa CMV Quantitation Standards
Advice regarding the use of the device: HPRA Ref: V27032

GE Medical Systems LLC
LightSpeed Ultra (8-slice MDAS), LightSpeed Plus (4-slice MDAS), LightSpeed QX/i (4-slice MDAS), LightSpeed 16 (MDAS Only), Discovery ST & Discovery LS
Advice regarding changes/updates made to instructions for use: HPRA Ref: V27126 

Integra MicroFrance SAS
Integra® MicroFrance® Monopolar instruments, Integra® MicroFrance® Bipolar Instrument Handle CEV669E
Advice regarding the use of the device: HPRA Ref: V27121

Lifetech Scientific
Lifetech CeraFlex™ Atrial Septal Defect (ASD) Occluders
Advice regarding a device removal: HPRA Ref: V27093

Lifetech Scientific
Lifetech CeraFlex™ Atrial Septal Defect (ASD) Occluders
Advice regarding the use of the device: HPRA Ref: V27093

Liko AB (Hill-Rom)
Liko® Universal SlingBar 350, SlingBar 450 and SlingBar 600
Advice regarding a device modification: HPRA Ref: V26895

Maquet Critical Care AB
FLOW-I system version 4.1
Advice regarding a software upgrade. HPRA Ref: V27275

Mavig GmbH
MAVIG Monitor suspensions used on INNOVA X100/IQ, INNOVA X1X1IQ, Advantx LCV+, Advantx LCA, Advantx LCLP+, Advantx LCN+ fluoroscopic imaging systems
Advice regarding a device modification. HPRA Ref: V26585

McKesson Medical Imaging Company
Horizon Medical Imaging (HMI)
Advice regarding a software upgrade: HPRA Ref: V27132

Medtronic
Covidien Curity™ All Purpose Gauze Sponges, Curity™ X-Ray Detectable Laparotomy Sponges, Kerlix™ X-Ray Detectable Laparotomy Sponges, Vistec™ X-Ray Detectable Sponges
Advice regarding a device removal: HPRA Ref: V27179

Medtronic Inc.
SynchroMed II Programmable Pump
Advice regarding a device removal: HPRA Ref: V27039

Mönlycke Healthcare
Barrier® EasyWarm®
Advice regarding a device removal: HPRA Ref: V26036

Nutricia Medical Devices BV
Flocare Infinity Giving Sets - Transition
Advice regarding the use of the device: HPRA Ref: V26575

Össur
Rebound® Cartilage / Rebound® Air Walker / Rebound® Diabetic Walker / Miami J Collar
Advice regarding a device modification: HPRA Ref: V27218

Philips
Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy EC
Advice regarding the use of the device: HPRA Ref: V26683

Philips
Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy EC
Advice regarding the use of the device: HPRA Ref: V26683

Philips Medical Systems (Cleveland) Inc
Extended Brilliance WorkSpace NM 2.0
Advice regarding a software upgrade: HPRA Ref: V27252

QIAGEN
QuantiFERON®-TB Gold (QFT®) TB-Antigen blood collection tubes
Advice regarding a device removal: HPRA Ref: V27080

Research Instruments Limited
Integra 3
Advice regarding a device modification: HPRA Ref: V27336

Roche Diagnostics
Elecsys Estradiol II and Elecsys Estradiol III
Advice regarding changes/updates made to instructions for use: HPRA Ref: V27011

Schiller AG
FRED Easyport
Advice regarding a software upgrade: HPRA Ref: V27210

Siemens
Artis zee systems with generator A100Plus or Artis zeego systems with software version VC21B.
Advice regarding a software upgrade: HPRA Ref: V27176

Siemens Medical Solutions USA, Inc. Molecular Imaging
E.CAM and Symbia E family
Advice regarding the use of the device: HPRA Ref: V27123

Smith & Nephew
TOPAZ MicroDebrider
Advice regarding a device removal: HPRA Ref: V27116

Terumo
Terumo® ACCUFORCE® PTCA Dilatation Catheter (ɸ2.5mm)
Advice regarding a device removal: HPRA Ref: V27117

Thermo Fisher Scientific Microbiology Basingstoke
OXOID NITROCEFIN+RECONSTITUTION FLUID 2X5VIALS
Advice regarding a device removal: HPRA Ref: V27262

Thermo Fisher Scientific Microbiology Basingstoke
Oxoid Antimicrobial Susceptibility Test Disc Ticarcillin/Clavulanic Acid (TIM85) CT0449B
Advice regarding a device removal: HPRA Ref: V27340

Vascular Solutions
Guardian® II Hemostasis Valve
Advice regarding a device removal: HPRA Ref: V27215

Verathon
GLIDESCOPE Video Laryngoscope Titanium Single-Use Blades
Advice regarding a device removal: HPRA Ref: V26982

Zimmer Biomet
Instinct Java System Instruments; Universal Clam System Instruments; UniWallis System Instruments
Advice regarding changes/updates made to instructions for use: HPRA Ref: V27028

Zimmer Biomet
Revitan proximal spout stems (Size 55-105) and Revitan proximal cylindrical stems (Size 55-105)
Advice regarding a device removal: HPRA Ref: V27211

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