Field Safety Notices

Medical Device Field Safety Notices

 

July 2024

corPatch easy

Thermofisher scientific Oncomine® Dx Express Test Panel

Philips Trilogy Evo, Trilogy Evo O2, and Trilogy EV300

Bruker Daltonics UMIC Colistin

Exmoor Plastics Ltd Aural Vent Tubes

Exmoor Plastics Ltd Silicone Sheets, Discs and Strips

 

June 2024

Smiths Medical Bivona® Tracheostomy Tubes

Terumo Spectra Optia Apheresis System

Siemens Healthineers Atellica IM Analyzer & ADVIA Centaur XPT System

Hologic Horizon X-Ray Bone Densitometer (DXA)

GE HealthCare MR Systems

ZOLL G5 Semi-Automatic AED Product Family

Philips Wired Avalon Ultrasound Transducer

Baxter iLED 7 Surgical Lights

SLE6000 Infant Ventilator

Medtronic Cobalt XT™, Cobalt™ and Crome™ ICD

Boston Scientific Capio SLIM Suture Capturing Device

 

May 2024

Carescape multi-parameter patient monitors

MyoSPECT and MyoSPECT ES Systems

Medtronic Ascenda™ Intrathecal catheters

Idylla™ EGFR Mutation Test

Integra CUSA® Handpiece

Radiometer BL800 Basic and ABL8XX FLEX analyzers

Mindray BeneHeart D1 Automated External Defibrillator


April 2024

STRYKER EXETER 2.5 I M PLUG

Medtronic Vanta™ Implantable Neurostimulator

HeartSine Samaritan PAD and Omron HDF-3500

Intersurgical Various Mapleson F Anaesthetic Breathing Systems

Vercise Genus™ Deep Brain Stimulation (DBS)

Fabian HFO Classic and Fabian HFOi ventilators

Infinity M500 Docking Station

JENX Supine 2 and Multistander 2

IONA® Nx cfDNA Library Preparation Dx Kit

Randox Total Bilirubin Vanadate Oxidation Method

Philips MR systems

 

August 2021

Philips Respironics CPAP and Bi-Level PAP Devices

Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models