My HPRA: Register

Summary of Field Safety Notices - January 2019

Notice type: 3rd Party Publications

Date: 01/02/2019

  

Further Information:
Bayer Medical Care Inc.
MAVIG® Portegra2 Overhead Counterpoise System
Advice regarding a device modification. HPRA Ref: V38309


Beckman Coulter
COULTER® EPICS® XL™ Flow Cytometer, COULTER EPICS XL-MCL™ Flow Cytometer and FC 500™ Series Flow Cytometers. Follow up FSN 1
COULTER® EPICS® XL™ Flow Cytometer, COULTER EPICS XL-MCL™ Flow Cytometer and FC 500™ Series Flow Cytometers. Follow up FSN 2
Advice regarding the use of the device. HPRA Ref: V34333


Biomerieux Inc
VITEK® 2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards 
Advice regarding the use of the device. HPRA Ref: V38565


Caesarea Medical Electronics
T34 Ambulatory Syringe Pump
Advice regarding a device modification. HPRA Ref: V38597


Cellpath Limited 
Claritex WhiteCoat slide
Advice regarding a device removal. HPRA Ref: V37967


Cepheid
GeneXpert Systems
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38225


Cook Endoscopy
Captura Biopsy Forceps
Advice regarding a device removal. HPRA Ref: V38295


Cook Medical
Bander Ureteral Diversion Open-End Stent Set, Percutaneous Entry Set, Percutaneous Pigtail Nephrostomy Set, PTFE Wire Guide,
Roadrunner® Hydrophilic PC Wire Guide, Sof-Flex® Double Pigtail Ureteral Stent Set, Sof-Flex® Multi-Length Ureteral Stent Set, Universa® Soft Ureteral Stent Set, Urethral Dilation Balloon Catheter with Open Tip. 
Advice regarding a device removal. HPRA Ref: V38388


Dako North America Inc 
Autostainer Slide Racks
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38311


Edwards Lifesciences LLC
Swan Ganz Thermodilution Catheter
Advice regarding a device removal. HPRA Ref: V38423


Elekta
MOSAIQ
Advice regarding a software upgrade. HPRA Ref: V38120


Elekta
MOSAIQ
Advice regarding a software upgrade. HPRA Ref: V38258


Endologix
Nellix EndoVascular Aneurysm Sealing System
Advice regarding a device removal. HPRA Ref: V38413


Fannin LIP 
W11064 X + V Agar
Advice regarding a device removal. HPRA Ref: V38588


GE Healthcare
CARESCAPE B850 patient monitor
Advice regarding the use of the device. HPRA Ref: V38222


Getinge
Fibrocleaner
Advice regarding a device modification. HPRA Ref: V38010


Halyard
ENTRAL™ Side Load Clamp for Tubes ≤ 14Fr – (SMALL)
Advice regarding the use of the device. HPRA Ref: V38140


Herdegen SAS
Elbow crutches Advance bi-matières (all colors) / Elbow crutches Canne Advance bi-matières (all colors)
Advice regarding a device removal. HPRA Ref: V37177


Implant Direct Sybron Manufacturing LLC
Interactive Precision IO Scan Adapter. FSN 1
Interactive Precision IO Scan Adapter. FSN 2
Advice regarding a device removal. HPRA Ref: V38074


Medtronic
Covidien Parietex™ Composite Parastomal Mesh
Advice regarding a device removal. HPRA Ref: V37593


Medtronic
Stealthstation Cranial and Synergy Cranial
Advice regarding the use of the device. HPRA Ref: V37754


Medtronic
Adapta™, Versa™, Sensia™, Relia™, Attesta™, Sphera™, and Vitatron™ A, E, G, Q series.
Advice regarding a device removal. HPRA Ref: V38564


Medtronic Inc.
CareLink Programmer & CareLink Encore Programmer
Advice regarding a software upgrade. HPRA Ref: V38574


MicroPort CRM S.r.l.
Platinium ICDs and CRT-Ds. FSN 1
Platinium ICDs and CRT-Ds. Follow Up FSN 
Advice regarding a software upgrade. HPRA Ref: V36478


Ottobock
Push Valve/Mag Valve
Advice regarding a device removal. HPRA Ref: V38315


Philips
Philips Volcano V2.5 FFR/iFR Software
Advice regarding a software upgrade. HPRA Ref: V38357


Philips
Philips PageWriter TC Cardiographs (TC20/30/50/70)
Advice regarding a software upgrade. HPRA Ref: V38556


Philips
Philips Efficia CM Monitors
Advice regarding a software upgrade. HPRA Ref: V38566


Philips Medical Systems
Xper Flex Cardio Patient Monitoring System
Advice regarding a software upgrade. HPRA Ref: V38379


Philips Medical Systems Nederland B.V. 
Intera, Enterprise, Achieva, Achieva XT, Achieva Conversion, Panorama HFO, Ingenia, Smartpath to dStream, Multiva, Prodiva, MR-OR, MR-RT, MR-Linac and MR-Marlin MR systems.
Advice regarding a device modification. HPRA Ref: V38371


Richard Wolf GmbH
TEXAS Bronchoscope Tube
Advice regarding a device removal. HPRA Ref: V38249


Roche Diagnostics
BILT3, IGM-2, and LACT2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38105


Schiller
CARDIOVIT MS-2007; MS-2010; MS-2015
Advice regarding the use of the device. HPRA Ref: V38196


Seers Medical
SEERS Medical Bariatric Drop End Couches – Single & Dual Foot Sections
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36591


Siemens
Biograph Horizon
Advice regarding a device modification. HPRA Ref: V38166


Stago
STA® – VWF:RCo (ref. 01191)
Advice regarding the use of the device. HPRA Ref: V38634


Teleflex Medical
Percuvance® Percutaneous Shaft 29cm and  Percuvance® Percutaneous Shaft 36cm
Advice regarding a device removal. HPRA Ref: V38432


ThermoFisher Scientific 
ThermoScientificTM OxoidTM Meropenem 32 M.I.C.E. strip, MA0121D&F
Advice regarding a device removal. HPRA Ref: V38438


UniMed
Various Medical devices (needles)
Advice regarding a device removal. HPRA Ref: V38345


Unomedical a/s 
MiniMed™ Mio™ Advance (MMT-242, MMT-242T, MMT-242600, MMT-247, MMT-247T, MMT-247600). FSN 1
MiniMed™ Mio™ Advance (MMT-242, MMT-242T, MMT-242600, MMT-247, MMT-247T, MMT-247600). Letter
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38338


WEST Pharma. Services IL, Ltd. 
VIAL2BAG, VIAL2BAG (DC) 13mm, VIAL2BAG (DC) 20mm, I.V. FLUID TRANSFER SETS
Advice regarding a device removal. HPRA Ref: V38636

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