Field Safety Notice - 15 to 19 January 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 January 2018

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

Abbott: ARCHITECT c4000 / c8000 / c16000 cuvette segments

8 December 2018

IVDs, clinical chemistry

MHRA reference: 2018/001/011/291/003

Ad-Tech Medical Instrument Corporation: Disposable Drill Kit

03 January 2018

Surgical power tools

Model: DDK2-2.4-30X, DDK2-2.8-30X

MHRA reference: 2018/001/005/601/008

Baxter: PrisMax Hemodialysis Machine 115369

27 June 2017

Dialysis, haemofilters

MHRA reference: 2017/006/019/291/028

Creganna Medical (Boston Scientific): Zurpaz Steerable Sheath Set

02 June 2017

Vascular cannula and catheters

MHRA reference: 2017/005/031/601/007

Greiner Bio-One: MiniCollect® Complete 1 ml 9NC

18 January 2018

IVDs, specimen receptacles

Model: 450556

MHRA reference: 2018/001/018/291/019

Hocoma: Andago V2.0

CAPA-2347

Therapy, Standing & Walking

MHRA reference: 2018/001/016/291/010

Maquet (Gentinge): VOLISTA

26 December 2017

Lamps & lights

Model: All VOLISTA StandOP, Triop and Access surgical lights

MHRA reference: 2018/001/005/291/011

Medtronic: AFFINITY® NT Cardiotomy/Venous Reservoir (CVR) Stand-Alone

January 2018

Infusion & transfusion, heart lung circuits

Model: 95249, 61399409462

MHRA reference: 2018/001/017/291/012

Philips Medical Systems: Allura Xper Systems

20 December 2017

X ray, fluoroscopy systems

Model: 722001, 722002, 722003, 722010, 722026, 722005, 722011, 722027, 722006, 722012, 722028, 722008, 722013, 722015, 722023, 722035, 722020, 722029, 722038, 722039, 722058, 722059

MHRA reference: 2018/001/012/291/002

Philips Medical Systems: Brilliance CT Big Bore

02 January 2018

Computed tomography

Model: Brilliance Big Bore Oncology CT– 728243, Brilliance Big Bore Radiology CT- 728244

MHRA reference: 2018/001/015/291/016

QIAGEN: therascreenPyrosequencing assays

16 January 2018

IVD, genetic testing

MHRA reference: 2018/001/018/291/012

Radiometer: PICO70

FAN 915-377

Storage & collection devices

MHRA reference: 2018/001/011/291/007

Rocialle: IV Cannulation Pack - Barnsley District

19 January 2018

Bandages and tapes

Model: RML112-180

MHRA reference: 2018/001/019/291/001

Smiths Medical: Medfusion® Model 3500; Medfusion® Model 4000

12 January 2018

Infusion systems

MHRA reference: 2018/001/015/291/002

Smith & Nephew: RT-PLUS MOD FEMORAL COMP. RIGHT 4 CEM RT-PLUS FEMORAL COMPONENT RIGHT 4 CEM

15 January 2018

Joint prosthesis, knee

MHRA reference: 2018/001/016/291/011

Updates to this page

Published 23 January 2018