Field Safety Notices: 30 November to 4 December 2020

List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 2020.

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Aidence: Veye Chest

November 2020

Picture archiving and communication system (PACS)

Model: 2

MHRA reference: 2020/012/001/601/002

Boston Scientific: Hot AXIOS™ (See FSN)

01 December 2020

Implants, non active, non vascular stents

Model: See FSN

MHRA reference: 2020/012/002/291/001

Boston Scientific: EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD

December 2020

Implants, active, cardiac subcutaneous system

Model: Model A209 - A219

MHRA reference: 2020/012/003/291/003

Implantcast: IFU/ ST: EcoFit® cup / EcoFit® cup EPORE®

30 November 2020

Joint Prosthesis, Hip

Model: Ecocuope, ecoepope 09300038, 38000025, 38000030, 38000035, 38000040, 38000530, 38000535, 38000540.

MHRA reference: 2020/012/001/701/004

Medtronic: TA™ Auto SutureTM Vascular Stapler with DST SeriesTM Technology 30mm -V3

November 2020

Staples and staple guns

Model: TA30V3L, TA30V3S

MHRA reference: 2020/011/030/291/001

Merit Medical: Prelude SNAP™; Worley™

1721504-08/31/20-005R

Vascular cannula and catheters

MHRA reference: 2020/009/016/291/001

Philips Medical Systems: JETStream® Workspace

November 2020

PET-CT

Model: 882310, 882311, 882313

MHRA reference: 2020/012/002/291/003

Roche Diagnostics: Cobas 8000 Core Unit, model number: 05641446001

cobas pro sample supply unit, model number: 08464502001 cobas c 513 analyzer commercial system, model number: 07649142001

November 2020

IVDs, clinical chemistry

model number: 05641446001, 08464502001 & 07649142001

MHRA reference: 2020/011/030/291/004

Siemens: ADVIA and Atellica GGT reagent

November 2020

IVDs, clinical chemistry Model: ADVIA SMN 10309495,10316298 Atellica SMN 11097597

MHRA reference: 2020/011/027/601/002

Siemens Healthcare: Artis zee/Q/Q.zen

November 2020

X Ray, Fluoroscopy Systems

Model: Artis zee/Q/Q.zen sytems with siemens healthineers table (Tilt/Step, OR) and with software version VD11E

MHRA reference: 2020/011/030/601/005

Silony Medical: Roccia Hooked Implant Driver ; RI-1342

13 November 2020

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2020/012/003/487/001

Stryker: Stryker SmartLife Large Aseptic Housings

April 2021

Surgical power tools

Model: 7126-120-000

MHRA reference: 2020/012/001/487/002

The Binding Site: Optilite Freelite kappa free kits

30 November 2020

IVDs, clinical chemistry

Model: LK016.OPT, LK016.10.OPT, LK016.M.OPT

MHRA reference: 2020/012/001/601/001

Wallac (PerkinElmer): Vanadis Core Buffer kit

27 November 2020

IVDs, viral microbiology

Model: Instrumentation/ platform 3223-0010

MHRA reference: 2020/011/027/487/008

Updates to this page

Published 7 December 2020