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Summary of Field Safety Notice – September 2015

Notice type: 3rd Party Publications

Date: 02/10/2015

  

Further Information:
Summary of Field Safety Notices - April 2015

3rd party publications

Date

Further information

Alba Bioscience
ALBAclone Anti-Leb Blood Grouping Reagent
Advice regarding a device removal. HPRA Ref V25609

BD
BD Plastipak Syringes / BD Oral Syringes
Advice regarding the use of the device. HPRA Ref V25649

Biocartis
Idylla KRAS Mutation Test
Advice regarding a device removal.HPRA Ref V25112

BioRad
Anti-Jka
Advice regarding a device removal. HPRA Ref V24917

Blatchford
Endolite Elite Blade and Endolite Javelin
Advice regarding a device modification. HPRA Ref V25608

Boston Scientific
EndoViveTM One Step ButtonTM; EndoViveTM Button Decompression Tube; EndoViveTM Low Profile Replacement Button
Advice regarding a device removal. HPRA Ref V25613

CareFusion
Alaris Syringe Pumps
Advice regarding changes/updates made to instructions for use. HPRA V25585

Dako
EnVision FLEX
Advice regarding a device removal. HPRA Ref V25537

DePuy Synthes
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument
Advice regarding a device removal.HPRA Ref V25636

DiaSys Diagnostics Systems GmbH
Tests based on Trinder reactions
Advice regarding changes/updates made to instructions for use. HPRA Ref V25448

Hill-Rom
Liko Viking L, Viking M, Viking XL, and Viking 300 Mobile Lifts - Potential Actuator Damage
Advice regarding a device modification  HPRA Ref V24667

JenaValve 
JenaValve TAVI System
Advice regarding the use of the device. HPRA Ref V25561

LifeHealth
IRMA TRUpoint CC Cartridges / IRMA TRUpoint BG Cartridges
Advice regarding a device removal. HPRA Ref V25672

Medtronic
Medtronic Navigation Cannulated Taps
Advice regarding changes/updates made to instructions for use. HPRA Ref V24414

Medtronic CryoCath LP
CryoConsole
Advice regarding a device modification. HPRA Ref V25491

Medtronic MiniMed
Medtronic MiniMed 640G Insulin Pump
Advice regarding a device removal. HPRA Ref V25689

P3 Medical Ltd, Armstrong Medical
Vented Tracheal Tube Introducer with Oxygen Connector, 14ch 750 mm
Advice regarding a device removal. HPRA Ref V25648

PAHSCO
Pediatric Enteral Feeding Tube
Advice regarding a device removal. HPRA Ref V25206

Pennine Healthcare
Laryngeal Suction Tube with Soft Tip
Advice regarding a device removal HPRA Ref V25612

Philips Healthcare
Allura systems, Actuator Monitor Ceiling Suspension
Advice regarding the use of the device. HPRA Ref V24832

Physio Control
Lifepak 1000 Defibrillator
Advice regarding a software upgrade. HPRA Ref V25493

Sentinel
Ammonia Ultra
Advice regarding a device removal. HPRA Ref V25665

Siemens
Digital Linear Accelerators of type Primus ONCOR and ARTISTE running Control Console software version 12.0.25 or 13.0.65 and syngo RT Therapist running software version 4.2.110 or 4.3.SP1
Advice regarding a software upgrade. HPRA Ref V25376

Stryker Orthopaedics
Exeter Small Tapered Pin Reamer and Exeter Large Tapered Pin Reamer
Advice regarding a device removal. HPRA Ref V25661

Stryker Orthopaedics
LFIT V40 Tapers, V40 Tapers and PCA Tapers Vitallium Femeral Heads
Advice regarding a device removal. HPRA Ref V25574

The Surgical Company International BV / The 37Company 
Fluido Trauma Set (671500)
Advice regarding a device removal. HPRA Ref V25580

Thermofisher Scientific
Glucose (GOD-POD); Uric Acid (AOX); Triglycerides; Cholesterol; Creatinine (Enzymatic); HDL- Cholesterol Plus; LDL-Cholesterol
Advice regarding the use of the device. HPRA Ref V25641

Thermofisher Scientific
CP11410 Autoread Mueller-Hinton Broth W/TES W/ Lysed Horse Blood, CP112-10 Mueller-Hinton Broth W/ TES W/ Lysed Horse Blood, T3462 Sensititre Cation Adjusted Mueller-Hinton Broth W/TES, and T3462-10 Sensititre Cation Adjusted Mueller-Hinton Broth W/TES.
Advice regarding a device removal. HPRA Ref V25546

Thoratec Corporation
HeartMate II LVAS System Controler
Advice regarding the use of the device. HPRA Ref V25605

Weinmann Emergency Medical Technology
MEDUMAT Transport ventilator (with and without CO2 measurement); only devices with software version 5.x are affected
Advice regarding a software upgrade. HPRA Ref V25520

Welch Allyn Ltd
KleenSpec Corded Illumination System
Advice regarding the use of the device. HPRA V25634

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