Field Safety Notice: 27 to 31 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 May 2019

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: Alinity i BNP Calibrators, Alinity i BNP Controls

24 May 2019

IVDs, clinical chemistry

MHRA reference: 2019/005/029/701/016

Abbott: Alinity ci-series System Control Module

21 May 2019

IVDs, clinical chemistry

MHRA reference: 2019/005/023/701/004

Abbott: ARCHITECT BNP Calibrator kit, ARCHITECT BNP Control kit

24 May 2019

IVDs, clinical chemistry

MHRA reference: 2019/005/029/701/017

Arjo: System 2000 including Rhapsody, Primo, PrimoFerro

FSN-POZ-001-2019 Bath and aids AP01300GB1010, AP31200GB0010, AP31300GB1010, AP31301GB1010, AP31800GB1000, AR01211GB1010, AR01800GB1000, AR31300GB1010, AR31800GB1000, AR31800GB1010, AR32201GB1110, AR32811GB1000, AS31801GB0000, AS31811GB0010, AR01300GB1010, AR32301GB1110, AP31301GB1010, AP31300GB1010, AR31300GB1010, AR31800GB1000, AP32211GB1000, AR31200GB1010

MHRA reference: 2019/005/021/601/010

Becton Dickinson: BD Microtainer® Tubes

06 June 2019 IVDs, Specimen Receptacles

MHRA reference: 2019/005/020/291/011

Medtronic: Endo GIATM Surgical Stapling Single Use Loading Units, Tri-StapleTM 2.0 Intelligent Reloads and Cartridges

May 2019

Staples and Staple Guns EGIA30AMT, EGIA45CTAMT, EGIA60AXT, EGIA60CTAMT, SIG30AMT, SIG45AXT, SIG45CTAMT, SIG60AXT, SIG60CTAMT, EGIA45AMT, EGIA60AMT

MHRA reference: 2019/005/030/487/006

EKOS Corp: EKOS Control System 4.0

20 May 2019

Ultrasound, imaging

MHRA reference: 2019/005/029/487/005

GE: Centricity Universal Viewer

FMI 85449 Endoscopes, televisual systems

MHRA reference: 2019/005/030/487/005

Leonhard Lang: Mindray- Weinmann defibrillation electrodes

15 May 2019

Defibrillators, non-implantable 50607 MDF1A_MIND DF81C MINDRAY ADULT 0-1-10-60

MHRA reference: 2019/005/015/291/007

LivaNova: VNS Therapy® SenTiva® Generator

28 May 2019

Implants, active, stimulators, neuro Model 1000

MHRA reference: 2019/005/030/487/003

Randox Laboratories: HUMAN ASSAYED MULTI-SERA Level 2

23 May 2019

IVDs, clinical chemistry HN1530

MHRA reference: 2019/005/023/601/003

Richard Wolf: CUTTING ELECTRODE MONO 11.5FR 0

27 May 2019

Surgical instruments, minimal access 8416.03

MHRA reference: 2019/005/030/228/010

Roche Diagnostics: IGA-2 (Tina-quant IgA Gen.2)

CN-431825 IVDs, immunology

MHRA reference: 2019/005/022/701/010

Roche: Elecsys Syphilis (200 test/kit)

May 2019

IVDs, bacteriology

MHRA reference: 2019/005/024/701/003

Siemens: ARTIS zee and AXIOM Artis

13 May 2019

X Ray, fluoroscopy systems

MHRA reference: 2019/005/028/601/008

Stryker: 2.7 Degree Straight Sagittal Saw and 2.7 Degree Angled Sagittal Saw

09 May 2019

Surgical power tools

MHRA reference: 2019/005/009/487/028

TEC COM GmbH: TECOtherm NEO

28 May 2019

Blood/fluid warming systems

MHRA reference: 2019/005/030/487/002

Teleflex: Sheridan

27 May 2019

Airway devices

MHRA reference: 2019/005/030/487/001

Updates to this page

Published 3 June 2019