Field Safety Notices - 17 to 21 February 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 February 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

Advanced Bionics: HiRes Ultra with HF Mid-Scala Electrode, HiRes Ultra with HF SlimJ Electrode, HiRes Ultra 3D with HF Mid-Scala Electrode and HiRes Ultra 3D with HF SlimJ Electrode

18 February 2020

Active implants, cochlear and middle ear implants

CI-1600-04, CI-1600-05, CI-1601-04 and CI-1601-05

MHRA reference: 2020/002/018/291/001

Bellco - Medtronic: MICROPLAS Plasmafilter

February 2020

Plasma filter

IBP4102, IBP4103, IBP4104

MHRA reference: 2020/002/014/291/007

Cardiac Science: Powerheart G3 Elite AED

21 January 2020

Defibrillators, non implantable

Model: 9790A-1002, 9790E-1002

MHRA reference: 2020/001/030/487/004

Change Healthcare: McKesson Cardiology ECG Management

10 February 2020

ECG

MHRA reference: 2020/002/011/701/030

Diagnostica Stago: STA Compact, STA Compact Max, STA-R Evolution, STA-R Max

RIS-19-0037

Coagulation

MHRA reference: 2020/002/014/291/008

Limacorporate: Modulus & Revision stems

2 August 2019

Joint Prosthesis, Hip

MHRA reference: 2020/002/019/291/005

Limacorporate S.p.A: SMR Shoulder cementless finned stem L.80mm dia.19m

19 February 2020

Joint prosthesis, shoulder

Model: SMR Shoulder cementless finned stem L.80mm dia.19m 1304.15.190

MHRA reference: 2020/002/020/291/010

MEDTRON AG: MR-Set ELS 65ml, ELS 65ml syringe

REK07875

Injection devices

REF 317602-000 (Set), REF 316065-000 (Syringe)

MHRA reference: 2020/002/013/291/013

Neovasc: Neovasc Reducer

FCA 19-001-C Implants

Non active, coronary stents

RED-001

MHRA reference: 2020/002/006/701/021

Siemens: Artis zeego & Artis zee/Q./Q.zen

February 2020

X Ray, fluoroscopy systems

MHRA reference: 2020/002/017/601/007

Siemens: Atellica CH Ethyl Alcohol (ETOH)

ACHC 20-07 – February 2020

IVDs, clinical chemistry

MHRA reference: 2020/002/019/601/001

Siemens: ARTISTE MV Systems; ONCOR; PRIMUS; MEVATRON

TH002/20/S

Radiotherapy

8139789; 5863472; 5857912; 7360717; 5857920; 4504200

MHRA reference: 2020/002/017/601/008

Updates to this page

Published 24 February 2020