Field Safety Notice - 24 to 28 July 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 July 2017
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
Becton Dickinson: BD MultiTEST™ CD3/CD8/CD45/CD4
26 July 2017
IVDs, cytopathology & histopathology
MHRA reference: 2017/007/027/701/004
Boston Scientific: AdVance XP Needle Passers
AdVance XP Procedure Pack
July 2017
Implants, non active, implantable incontinence and prolapse devices
MHRA reference: 2017/007/027/291/004
DePuy: CORAIL® COXA VARA HIGH OFFSET STEM
July 2017
Joint prosthesis, hip
Model: 3L93709;L20314
MHRA reference: 2017/007/027/701/021
Elekta: MOSAIQ
June 2017
Radiotherapy
MHRA reference: 2017/006/029/701/040
FUJIFILM: Amulet S/ Amulet F/ Innovality
FFUID 20170629
Mammography
MHRA reference: 2017/007/025/291/004
Hitachi (Roche): cobas c 501 / cobas c 502
20 July 2017
IVDs, clinical chemistry
Model: 04745914001 / 05964067001
MHRA reference: 2017/007/024/291/027
Hitachi: The immunology modules:
- MODULAR ANALYTICS <E170> (GMMI 03617505001)
- MODULAR ANALYTICS EVO <E170> (GMMI 04998642001)
- cobas e 601 module (GMMI 04745922001)
- cobas e 602 module (GMMI 05990378001
21 June 2017
IVDs, clinical chemistry
MHRA reference: 2017/006/026/701/001
Jarvik Heart: Jarvik 2000 VAS, Adult VAD, Post-Auricular Cable
21 July 2017
Implantable ventricular assist devices
Model: JHI-001
MHRA reference: 2017/007/027/601/001
LivaNova: PLATINIUM
24 July 2017
Implants, active, defibrillators
Model: PLATINIUM VR 1210 PLATINIUM VR 1240 PLATINIUM DR 1510 PLATINIUM DR 1540 PLATINIUM CRT-D 1711 PLATINIUM CRT-D 1741 PLATINIUM 4LV CRT-D 1744 PLATINIUM SonR CRT-D 1811 PLATINIUM SonR CRT-D 1841 PLATINIUM 4LV SONR CRT-D 1844
MHRA reference: 2017/007/025/291/009
Mathys: Affinis CoCr head 43/15/2
25 July 2017
Joint prosthesis, shoulder
Model: 102.02.00.15.0
MHRA reference: 2017/007/025/701/004
Meditech Systems: Meditech Systems Ltd - Adult APL Valve
24 July 2017
Breathing system components
Model: AC22APL60
MHRA reference: 2017/007/024/601/005
Phadia AB ( ThermoFisher Scientific)
22 June 2017
IVDs, immunology
Model: Phadia 1000
MHRA reference: 2017/006/022/601/005
Physio-Control:LIFEPAK® 15 MONITOR/DEFIBRILLATOR
July 2017
Defibrillators, non implantable
MHRA reference: 2017/007/019/701/015
Prism
7 July 2017
Hoists and slings
Model: 320
MHRA reference: 2017/004/018/401/005
QIAGEN
10 July 2017
IVD, genetic testing
Model: ipsogen BCR-ABL1 Mbcr IS-MMR Kit, ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit, ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit
MHRA reference: 2017/007/025/701/009
Roche: Accu-Chek® Insight
SB_RDC_2017_04
Infusion systems
MHRA reference: 2017/007/025/291/019
Teleflex: Percuvance Percutaneous Surgical System
20 July 2017
Surgical instruments, articulated holding
MHRA reference: 2017/007/024/291/025
Thermo Fisher Scientific: Thermo Scientific Remel Vibrio Cholerae Ogawa agglutinating serum R30165201
25 July 2017
IVDs, bacteriology
MHRA reference: 2017/007/026/601/005
Thermofisher Scientific: Thermo Scientific Remel E. coli Polyvalent and Monovalent Agglutinating Sera
25 July 2017
IVDs, bacteriology
Model: Various
MHRA reference: 2017/007/026/60 1/006