Summary of Field Safety Notices - April 2019

Notice type: 3rd Party Publications

Date: 01/05/2019

 

Further Information:
3M
3M™ Reston™ Self-Adhering Foam Pads, References 1560M, 1561H
Advice regarding the use of the device. HPRA Ref: V39512


Abbott
Alinity HQ analyser
Advice regarding the use of the device. HPRA Ref: V39505


Abbott
Alinity i Processing Module, TED (Thermo-Electric Device) Engine, Reagent cooler, CABLE, POWER OUT, TED CNTRLER
Advice regarding a device modification. HPRA Ref: V39638


Abbott
Alinity c Cuvette Segment
Advice regarding a device modification. HPRA Ref: V39755


AngioDynamics
Solero Microwave Tissue Ablation (MTA) System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V39839


Apollo Healthcare
Pandora Profiling Bed
Advice regarding the use of the device. HPRA Ref: V30819


ARC Laser GmbH
Wolf 445nm
Advice regarding a software upgrade. HPRA Ref: V39503


Axis-Shield Diagnostics Ltd
Alere NT-proBNP Control/Alere NT-proBNP Calibrator
Advice regarding a device removal. HPRA Ref: V39849


BioKit S.A
Quantia RF
Advice regarding a device removal. HPRA Ref: V39768


Boston Scientific 
Xenform™ Soft Tissue Repair Matrix, Uphold™ Lite with Capio SLIM Vaginal Support System, Polyform™ Synthetic Mesh, Pinnacle™ LITE Pelvic Floor Repair Kit, Posterior
Advice regarding a device removal. HPRA Ref: V39782


Cook Incorporated
Kwart Retro-Inject™ Stent Set, Salle Intraoperative Pyeloplasty Stent Set
Advice regarding changes/updates made to instructions for use. HPRA Ref: V39774


Cook Medical
Zenith Alpha Abdominal Endovascular Graft
Advice regarding a device removal. HPRA Ref: V39858


Covidien
Yankauer Suction Tubing, Foley Catheter, Thoracic Catheter, Oxygen Tubing
Advice regarding a device removal. HPRA Ref: V35165


Covidien llc
Mahurkar Triple Lumen Catheter; Mahurkar Dual Lumen Catheter; Argyle Single Lumen Catheter
Advice regarding the use of the device. HPRA Ref: V39863


Datex-Ohmeda, Inc.
Aisys/Aisys CS2
Advice regarding a software upgrade. HPRA Ref: V39495


Dornier MedTech
Dornier Standard Diode and Nd:YAG Lightguides
Advice regarding a device removal. HPRA Ref: V39569


Draeger Medical Systems Inc.
Infinity Acute Care System (M540)
Advice regarding the use of the device. HPRA Ref: V39502


Edwards Lifesciences
Vamp Optima
Advice regarding the use of the device. HPRA Ref: V39489


Edwards Lifesciences
Miller Balloon (model 830515F) and Fogarty Dilation (model 830705F) Atrioseptostomy Catheters
Advice regarding a device removal. HPRA Ref: V39842


Fannin
Blood agar No.2+ Horse Blood,  Fastidious Anaerobic Agar+ Nat,  Staph/Strep Selective Agar Modified.
Advice regarding a device removal. HPRA Ref: V39536


GE Healthcare
Giraffe Bedded Warmer/Panda iRes Warmer
Advice regarding a device modification. HPRA Ref: V39486


Getinge - MAQUET GmbH
MEERA with and w/o Drive Unit
Advice regarding a device modification. HPRA Ref: V39509


Grifols Diagnostic Solutions Inc.
Procleix HEV Assay
Advice regarding a device modification. HPRA Ref: V39699


Hamilton Medical AG
HAMILTON-C6 Ventilator
Advice regarding a software upgrade. HPRA Ref: V39119


Hyaltech Limited
Visthesia 1.0% _ 090004
Advice regarding a device removal. HPRA Ref: V39848


Intelerad
IntelePACS
Advice regarding a software upgrade. HPRA Ref: V39891


Invacare Deutschland GmbH
BORA, DRAGON, MIRAGE, SPECTRA BLITZ, STREAM
Advice regarding a device removal. HPRA Ref: V39480


LivaNova Deutschland GmbH
Heater-cooler 3T
Advice regarding a device modification. HPRA Ref: V39007


MAQUET SAS
Volista STANDOP, Volista TRIOP
Advice regarding the use of the device. HPRA Ref: V39833


Medtronic
Endo Clinch™ II and Endo Grasp™ Auto Suture™ Grasper 5mm
Advice regarding a device removal. HPRA Ref: V39340


Medtronic
DRILL MINI-TREPHINATION 2.0mm
Advice regarding a device removal. HPRA Ref: V39463


Medtronic Inc.
Activa Clinician Programmer Application
Advice regarding a software upgrade. HPRA Ref: V39488


Philips Medical Systems
IntelliVue MX40 Patient Monitor
Advice regarding a software upgrade. HPRA Ref: V39708


Philips Medical Systems DMC GmbH 
MobileDiagnost wDR
Advice regarding the use of the device. HPRA Ref: V39526


Philips Medical Systems Nederland BV
MultiDiagnost Eleva, UroDiagnost Eleva, OmniDiagnost Classic & OmniDiagnost-Eleva
Advice regarding a device modification. HPRA Ref: V39430


Quidel Corporation
Quidel Triage TOX Drug Screen Control 1
Advice regarding a device removal. HPRA Ref: V39700


Randox Laboratories Ltd
Calcium
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38113


Roche Diagnostics
Vitamin D total II
Advice regarding a device modification. HPRA Ref: V39739


Topcon
Ophthalmic Data System IMAGEnet 6
Advice regarding a software upgrade. HPRA Ref: V39750


Zimmer GmbH
Foot and Ankle Inst. (Drill / Tap and Countersink)
Advice regarding a device removal. HPRA Ref: V39491


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