My HPRA: Register

Summary of Field Safety Notice – April 2018

Notice type: 3rd Party Publications

Date: 02/05/2018

  

Further Information:
Abbott
DPX-NT, DPX Bravo, DPX Duo, DPX-MD, Prodigy, Prodigy Advance Systems 
ARCHITECT Total T4 Calibrators
Advice regarding a device removal. HPRA Ref: V35453

ACUTRONIC Medical Systems AG
Fabian Evolution Healthcare
Advice regarding a device modification. HPRA Ref: V35195

Alere Technologies AS
Alere Afinion 2
Advice regarding a software upgrade. HPRA Ref: V35313

Arcoma AB
0180-lntuition & 0072-Precision
Advice regarding a device modification. HPRA Ref: V35378

Arcomed AG
Volumed µVP7000
Advice regarding the use of the device. HPRA Ref: V35420

B Braun
Askina Gel / Askina Calgitrol Paste
Advice regarding a device removal. HPRA Ref: V35683

Becton, Dickinson & Company (BD)
BD PosiFlush™ Heparin Lock Flush Syringes and BD™ Pre-Filled Normal Saline Syringes
Advice regarding a device removal. HPRA Ref: V35686

Chalice Medical
Paragon Oxygenators
Advice regarding the use of the device. HPRA Ref: V35620

Cook Inc.
Cook Vital-Port® Vascular Access System
Advice regarding a device removal. HPRA Ref: V33942

Cook Inc.
Soft-Trans Embryo Transfer Catheter
Advice regarding a device removal. HPRA Ref: V35429

Dako - Agilent Technologies Denmark ApS 
Monoclonal Mouse Anti-Pneumocystis Jiroveci Clone 3F6 & Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell Clone DBA.44
Advice regarding a device removal. HPRA Ref: V35298

Draeger Medical Systems, Inc.
Jaundice Meter, JM-103
Advice regarding changes/updates made to instructions for use. HPRA Ref: V34193

Draeger Medical Systems, Inc.
Jaundice Meter, JM-105
Advice regarding changes/updates made to instructions for use. HPRA Ref: V35600

Draeger Medical Systems, Inc.
Infinity Acute Care System (IACS) with Software Versions VG2.2 to VG4.1 and Infinity MCable Mainstream CO2 (M11.1) Revision 16 sensor
Advice regarding a software upgrade. HPRA Ref: V35612

GE Healthcare
DPX-NT, DPX Bravo, DPX Duo, DPX-MD, Prodigy, Prodigy Advance Systems
Advice regarding a software upgrade. HPRA Ref: V35409

GE Vingmed Ultrasound AS
TEE Probes
Advice regarding the use of the device. HPRA Ref: V35170

GE Vingmed Ultrasound AS
LOGIQ 9, LOGIQ E9,Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90 and Vivid E95
Advice regarding a device modification. HPRA Ref: V35477

Genicon Inc.
EZee Retrieval 550-000-000
Advice regarding a device removal. HPRA Ref: V35578

Greiner Bio-One GmbH
MiniCollect® Complete 1 ml 9NC Coagulation sodium citrate 3.2%, light blue cap, pre-assembled with Carrier Tube 13x75
Advice regarding a device removal. HPRA Ref: V34430

HOYA Corporation / Pentax Europe GmbH
PENTAX Duodenoscope ED34-i10T/ED3490TK FSN 1
PENTAX Duodenoscope ED34-i10T/ED3490TK FSN 2
Advice regarding a device removal. HPRA Ref: V35711

Implant Direct Sybron Manufacturing LLC
SwishTapered™ and SwishPlus™ Implant
Advice regarding the use of the device. HPRA Ref: V34361

Integra Life Sciences Services
TITAN™ Total Modular Shoulder System (TSS) Humeral Stem Trials
Advice regarding a device removal. HPRA Ref: V34364

IRIDEX Corporation
TruFocus LIO Premiere
Advice regarding a device removal. HPRA Ref: V35445

MedComp
CATHETER REPAIR KIT / 12F X 40CM TESIO CATH SET / 12F X 60CM TESIO CATH / 12F TESIO CATH /CUFF SET / 12F MOD TESIO CATHETER SET / TWO PART ADAPTOR / CATHETER REPAIR KIT / REPAIR KIT
Advice regarding a device removal. HPRA Ref: V35035

Philips Healthcare
HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs
Advice regarding the use of the device. HPRA Ref: V35048

Philips Medical Systems Nederland B.V. BIU Magnetic Resonance-site Best / Philips
Healthcare (Suzhou) Co. Ltd for Multiva 1.5T systems
T5, T10-NT, ACSNT, Intera 0.5T/1.0T, 1.5T, Achieva 1.5T, Multiva 1.5T, Ingenia CX 1.5T and Panorama 1.0T MR systems
Advice regarding a device modification. HPRA Ref: V35335

Philips Medical Systems Nederland BV
Allura Xper R9 systems and Azurion R1.1
Advice regarding a software upgrade. HPRA Ref: V35163

Philips Medical Systems Nederland BV
Allura Xper with FlexVision large screen monitor.
Advice regarding a software upgrade. HPRA Ref: V35332

Philips Medical Systems Nederland BV
MultiDiagnost Eleva. UroDiagnost Eleva & MultiDiagnost Eleva with Flat Detector
Advice regarding a device modification. HPRA Ref: V35337

Qiagen
therascreen KRAS Pyro Kit (24) CE (REF 971460), therascreen BRAF Pyro Kit (24) CE (REF 971470), therascreen EGFR Pyro Kit (24) CE (REF 971480), therascreen GIST RapidScreen Pyro Kit (REF 971510), therascreen NRAS Pyro Kit (24) CE (REF 971530), therascreen RAS Extension Pyro Kit (REF 971590), PyroMark Gold Q24 Reagents (5 x 24) CE (REF 971802)
Advice regarding a device removal. HPRA Ref: V34436

Roche
cobas 8000 modular analyzer cobas e801 module
Advice regarding a device modification. HPRA Ref: V35269

Roche
Elecsys Vitamin D total II
Advice regarding the use of the device. HPRA Ref: V35604

Schiller AG
CARDIOVIT AT-102 Plus
Advice regarding the use of the device. HPRA Ref: V35590

Siemens Healthcare GmbH
ONCOR™ and PRIMUS™ running Control Console software version 9.2.400
Advice regarding the use of the device. HPRA Ref: V35118

Siemens Medical Solutions USA, Inc.,
Ultrasound Acuson SC2000 Ultrasound System
Advice regarding a device modification. HPRA Ref: V35152

Smiths Medical
Portex® Thoracic Catheter and Connecting Tube
Advice regarding a device removal. HPRA Ref: V35527

Teleflex/Arow
Various Arrow Products
Advice regarding a device removal. HPRA Ref: V35518

Thermofisher
ThermoScientific™ Oxoid™ OX1 Oxacillin, CT0159B
Advice regarding the use of the device. HPRA Ref: V35634

ThermoFisher Scientific - Remel 
Thermo Scientific™ Remel™ Agglutinating Sera R30161201 - Salmonella H (gm), R30161301 - Salmonella H (gp), R30161401 - Salmonella H (gq)
Advice regarding the use of the device. HPRA Ref: V35693

Vital Healthcare Sdn. Bhd.
NovaLine® Tubing Sets for Hemodialysis
Advice regarding the use of the device. HPRA Ref: V35450



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