Field Safety Notice - 29 August to 1 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 1 September 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.
Beckman Coulter
17 August 2017
IVDs, viral microbiology
Model: N/A
MHRA reference: 2017/008/017/601/011
Erbe: Pneumo-Cryoprobe; flexible
07 July 2017
Surgical, diathermy
Model: Pneumo-Cryoprobe; flexible 20402-032, 20402-037, 20402-040
MHRA reference: 2017/008/024/291/013
Hamilton: Hamilton Ventilators C2/C3's
07 August 2017
Lung ventilators
MHRA reference: 2017/008/030/701/012
Hitachi
1 June 2017
IVDs, clinical chemistry
Model: cobas c 311 analyzer, cobas c 501 module, cobas c 502 module, cobas c 701 module, cobas c 702 module, cobas 8000 ISE module 900, cobas 8000 ISE module 1800
MHRA reference: 2017/003/008/291/014
Hitachi: Cobas 8000 core unit
16 August 2017
IVDs, clinical chemistry
Model: 05641446001
MHRA reference: 2017/007/024/701/012
Hitachi
17 August 2017
IVDs, clinical chemistry
Model: 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)
MHRA reference: 2017/006/026/701/001
Illumina: MiSeqDx Cystic Fibrosis 139-Variant Assay (2 Runs)
21 August 2017
IVD, genetic testing
Model: PN 15036580
MHRA reference: 2017/008/030/291/001
Jarvik Heart Inc: Reserve Battery/Charger
28 August 2017
Implantable ventricular assist devices
Model: JHI-303
MHRA reference: 2017/008/028/601/010
Philips: IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5
August 2017
Monitors, patient
Model: IntelliVue Multi Measurement Server M3001A, M3001AL, M3002A, M8102A, M8105A
MHRA reference: 2017/008/024/291/025
Sage Products: Oral Care products
24 August 2017
Oral swabs
MHRA reference: 2017/008/025/701/009
Siemens: Artis one
12 July 2017
X Ray, fluoroscopy systems
MHRA reference: 2017/008/025/601/004
Siemens: Artis zee biplane and Artis Q biplane
17 August 2017
X Ray, fluoroscopy systems
MHRA reference: 2017/008/024/601/007
Smiths Medical: Graseby™ 3300 Pump and Locking Accessories
24 August 2017
Infusion systems
Model: 0128-0025; 0128-0135; 0128-0136; and 0128-0451
MHRA reference: 2017/008/029/291/032
St. Jude Medical (Abbott): Pacemakers
28 August 2017
Implants, active, pacemakers
Model: PM1260, PM1240, PM1272, PM2260, PM2240, PM2272, PM3222, PM3242, PM3262, PM1272, PM2272, PM3542, PM3562, PM1210, PM2210, PM3210, PM1222, PM1224, PM1226, PM2216, PM2218, PM2220, PM2222, PM2224, PM2226
MHRA reference: 2017/008/029/291/019
St. Jude Medical (Abbott): Implantable Cardioverter Defibrillators - See FSN.
28 August 2017
Implants, active, defibrillators
Model: All model numbers of the affected devices
MHRA reference: 2017/008/029/291/020
The Binding Site: Human α-1-Antitrypsin Kit for use on SPAplus®
24 August 2017
IVDs, clinical chemistry
Model: NK034.S
MHRA reference: 2017/008/025/601/001
Thermofisher Scientific: Thermo Scientific Oxoid Antimicrobial Susceptibility Test disc MEL25 MECILLINAM
29 August 2017
IVDs, bacteriology
MHRA reference: 2017/008/030/601/001
Zimmer: Vanguard Open Box Femoral Component
30 August 2017
Joint prosthesis, knee
Model: Vanguard Open Box Femoral Component
MHRA reference: 2017/008/031/291/010
Zimmer: A.T. S® 2200TS and A.T.S® 4000TS
28 August 2017
Surgical equipment, tourniquets
MHRA reference: 2017/008/030/291/012