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