My HPRA: Register

Summary of Field Safety Notices - May 2018

Notice type: 3rd Party Publications

Date: 01/06/2018

  

Further Information:
ArjoHuntleigh AB
Akron Tilt Table
Advice regarding a device modification. HPRA Ref: V35830


Baxter
Prismaflex 7.XX Row, Prismaflex 8.XX Row
Advice regarding a software upgrade. HPRA Ref: V35826


BBraun
Vasofix Safety
Advice regarding the use of the device. HPRA Ref: V35844


Becton Dickinson and Company
BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
Advice regarding the use of the device. HPRA Ref: V35264


Boston Scientific
"Capio™ Suture Capturing Devices (SLIM, Standard, Open Access, RP)
Uphold LITE with Capio™ SLIM Vaginal Support System
Pinnacle™ Anterior Pelvic Floor Repair Kit
Pinnacle LITE Posterior with Capio SLIM Pelvic Floor Repair Kit"
Advice regarding changes/updates made to instructions for use. HPRA Ref: V34635


Coherex Medical
Coherex WaveCrest® Left Atrial Appendage Occlusion System (32mm) 
Advice regarding a device removal. HPRA Ref: V35901


Covidien 
Covidien Endo GIA™ Articulating Loading Units- FSN 1
Covidien Endo GIA™ Articulating Loading Units- FSN 2
Advice regarding a device removal. HPRA Ref: V35715


Datascope / Visamed / Getinge
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Advice regarding a device modification. HPRA Ref: V35773


DiaMed 
LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, DiaClon Type + Screen
Advice regarding the use of the device. HPRA Ref: V35374


DiaMex
QConnect HIVp24
Advice regarding the use of the device. HPRA Ref: V36036


DiaSys Diagnostic Systems GmbH
ALAT (GPT) FS (IFCC mod.), ATP Hexokinase FS, CK-MB FS, GLDH FS DGKC
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36031


Ethicon Endo Surgery , LLC
HARMONIC ACE® LAPAROSCOPIC 5MM DIAMETER SHEARS + ADAPTIVE TISSUE TECHNOLOGY
Advice regarding a device removal. HPRA Ref: V35762


Galt Medical Corporation
Centeze Centesis Catheter
Advice regarding a device removal. HPRA Ref: V35768


GE Healthcare Japan Corporation and GE Hangwei Medical Systems Co. Ltd.
GE Healthcare Revolution EVO & Optima CT660, CT670, CT680, CT540 Internal Electrical Cable Damage
Advice regarding a device modification. HPRA Ref: V35899


Getinge
All Arterial Cannulae and Customized Tubing Packs including the 3/8” Vent plug - FSN
All Arterial Cannulae and Customized Tubing Packs including the 3/8” Vent plug - Annex 1
All Arterial Cannulae and Customized Tubing Packs including the 3/8” Vent plug - Annex 2
Advice regarding a device removal. HPRA Ref: V35749


Heraeus Medical GmbH
PALACOS® and COPAL® bone cements
Advice regarding the use of the device. HPRA Ref: V35833


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


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


Invivo, a division of Philips Medical Systems
Xper Flex Cardio Patient Monitoring System - FSN
Xper Flex Cardio Patient Monitoring System - Addendum
Advice regarding changes/updates made to instructions for use. HPRA Ref: V35821

  
Kisco International
ODALYS STERILE – Curved rod Ø6 L35 à L75 & ODALYS STERILE – Cross link 37-49 et 49-73
Advice regarding a device removal. HPRA Ref: V34701


MAQUET SAS
Getinge Volista cupolas of model Access, StandOP, Triop and Quicklock
Advice regarding a device modification. HPRA Ref: V35920


Medical Intelligence Medizintechnik GmbH
HexaPOD evo RT System
Advice regarding the use of the device. HPRA Ref: V35835


Medtronic Ireland Limited
Covidien Endo GIA™ Articulating Loading Units - FSN 1
Covidien Endo GIA™ Articulating Loading Units - FSN 2
Advice regarding a device removal. HPRA Ref: V35715


Newdeal SAS
ADVANSYS®MLP-DLP; ADVANSYS® TTC; Large QWIX®; TIBIAXYS® and UNI-CP™- Sterile
Advice regarding a device removal. HPRA Ref: V35963


Newdeal SAS
HINTEGRA® Screws and HINTEGRA® SENSITIVE Screws - Sterile
Advice regarding a device removal. HPRA Ref: V35970


OriGen
Cell Culture Grade DMSO Solutions
Advice regarding the use of the device. HPRA Ref: V35526


Ottobock
17KL40=16 Orthotic knee joints
Advice regarding a device removal. HPRA Ref: V35815


Philips Medical Systems
IntelliVue MX40 Patient Monitor - FSN
IntelliVue MX40 Patient Monitor - Errata
Advice regarding changes/updates made to instructions for use. HPRA Ref: V35712


Philips Medical Systems Nederland BV
OmniDiagnost Classic & OmniDiagnost-Eleva
Advice regarding a device modification. HPRA Ref: V35745


Qiagen GmbH 
EZ1 DSP Virus Kit (48)
Advice regarding a device removal. HPRA Ref: V36027


Quotient
ALBAcyte®
Advice regarding the use of the device. HPRA Ref: V35774


Radiometer
ABL90 FLEX
Advice regarding a software upgrade. HPRA Ref: V35788


Randox
Liquid Assayed Specific Protein Controls - FSN
Liquid Assayed Specific Protein Controls - IFU 1
Liquid Assayed Specific Protein Controls - IFU 2
Liquid Assayed Specific Protein Controls - IFU 3
Advice regarding changes/updates made to instructions for use. HPRA Ref: V35778


Ranfac Corporation
Blue Suture Grasper
Advice regarding a device removal. HPRA Ref: V35398


Roche 
Tina-quant IgG Gen.2 on cobas c 311/501/502 analyzers
Advice regarding the use of the device. HPRA Ref: V36038


Roche Diagnostics
Urisys 1100
Advice regarding the use of the device. HPRA Ref: V35637


Roche Diagnostics, Roche Diabetes Care
Accu-Chek® Inform II blood glucose test strips, Accu-Chek Aviva blood glucose test strips - FSN 1
Accu-Chek® Inform II blood glucose test strips, Accu-Chek Aviva blood glucose test strips - FSN 2
Advice regarding a device removal. HPRA Ref: V35746


SAM Medical Products
SAM XT Extremity Tourniquet
Advice regarding a device removal. HPRA Ref: V35760


Siemens Healthcare Diagnostics
Dimension® clinical chemistry system and Dimension Vista® System
Advice regarding a device removal. HPRA Ref: V35717


Siemens Healthcare GmbH
Artis zee/Q/Q.zen
Advice regarding a device modification. HPRA Ref: V35872


Siemens Healthineers
Atellica® UAS 800 Analyzer
Advice regarding a software upgrade. HPRA Ref: V36039


Stryker
QuikFlap Neuro Implants:
Advice regarding a device removal. HPRA Ref: V35938


Stryker
Mako RIO System Irrigation Clip (Partial Knee Application only)
Advice regarding a device removal. HPRA Ref: V36017


Zimmer Biomet
Echo Instrument Case Shell - Outer Case Vault Only / Comprehensive Reverse Shoulder Instrument - Outer Case Vault Only - Surgeon FSN
Echo Instrument Case Shell - Outer Case Vault Only / Comprehensive Reverse Shoulder Instrument - Outer Case Vault Only - Distributor FSN
Advice regarding a device removal. HPRA Ref: V35873

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