Field Safety Notices

Medical Device Field Safety Notices

 

September 2024 

GE HealthCare Centricity PACS System

Smiths Medical Nasopharyngeal

Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300

Integra Codman® Surgical Patties & Strips

B. Braun Nutrifix Bag and Infusomat

 

August 2024

Atellica CI, Atellica IM and ADVIA Centaur CA 19-9 Bias

GE HealthCare Anesthesia Devices

Boston Scientific Vercise Genus Deep Brain Stimulation

BioMérieux VITEK® 2

Grifols Erytra-Eflexis Analyzer

Pennine Healthcare Intermittent Standard Nelaton Catheter

Alcon DAILIES TOTAL

Olympus HIGH FLOW INSUFFLATION UNIT

Smith & Nephew REGENETEN Tendon Anchors

Shimadzu SIL-40 Series

Medtronic Vanta™ Implantable Neurostimulator

ACUSON Juniper and Maple

Advanta VXT and Flixene Vascular Grafts with Slider GDS

 

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

Robinson Health Care Fast Aid Zinc Oxide Tape

Convatec Kaltostat (R) Wound Dressing & Rope

Elekta Unity Systems

Alcon A-OK 20G V-LANCE FULL HANDLE1.3MM SATIN Bn. 15W9CJ

BD Phoenix™ M50 & BD Phoenix™ 100 Instruments

McGRATH™ MAC Video Laryngoscope

 

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

Medtronic Magnetic Resonance Imaging (MRI) Eligibility status

 

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

Fisher & Paykel Airvo 2 and myAirvo 2 devices

Perrigo Physiomer Baby Unidose

 

March 2024

Covidien Auto Suture™ Structural Balloon Trocar & Auto Suture™ Blunt Tip Trocar

Randox Calibration Serum Level 3

Philips Trilogy Evo - Loss of Power Alarm

DiaMed/Bio-Rad Reagents for antibody screening tests

Karex Medline Endocavity 

Resmed Astral  100 and Astral 150 ventilator

Philips MR room cage installations

Philips OmniLab Advanced (OLA )

 

February 2024

Lentismed HYDROPHILIC URINARY CATHETER LENTY

Masimo TC- I Reusable Tip Clip sensors

Genedrive MT-RNR1 ID Kit

EMP Allergy Eye Mist

DiaMed/Bio-Rad IH-500

Asset Medical FLOWART® NEEDLE FREE VALVE SET WITH 1.2 MICRON FILTER

 

January 2024 

Medtronic Shiley™ Adult Flexible Tracheostomy Tube

Getinge Maquet SAS

Zimmer Dermacarriers TM II Skin Graft Carriers

Philips Trilogy Evo

ACE BLADDER EVACUATOR

Duet® External Drainage and Monitoring System (EDMS)


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