Field Safety Notices - 16 to 20 March 2020
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 March 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
Antec International: Rely+On Perasafe
01 September 2018
Disinfectants for medical devices
Model: All pack sizes: 16.2g; 81g; 162g, and; 810g
MHRA reference: 2020/002/024/601/006
Becton Dickinson: BD Alaris™ System PC Unit Model 8000 and 8015
04 February 2020
Infusion systems
Model: 8000; 8015
MHRA reference: 2020/002/013/291/001
Chromsystems Instruments: Multilevel Plasma Calibrator Set Neuroleptics 1
12 March 2020
IVDs, clinical chemistry
Model: 92028/XT; 0211/XT; 0212/XT
MHRA reference: 2020/003/017/291/003
Drive Devilbiss: Drive DeVilbiss Healthcare
16 March 2020
Oxygen concentrators
MHRA reference: 2020/003/018/601/003
Eppendorf: Centrifuges5910 R
28 November 2019
Centrifuges
MHRA reference: 2020/003/019/291/002
Euroimmun: Anti-Zika Virus ELISA IgG
04 March 2020
IVDs, viral microbiology
MHRA reference: 2020/003/005/291/010
GCE: COMBILITE
10 February 2020
Regulators for gas cylinders
MHRA reference: 2020/003/019/291/006
Philips: Philips Azurion 7 M20
26 February 2020
X ray, fluoroscopy systems
Model: 722079
MHRA reference: 2020/002/028/291/005
Philips: SensaVue Patient Entertainment System
05 February 2020
Magnetic resonance, equipment & accessories
Model: 9896-032-0815X – SensaVue HD 9896-032-0872X – SensaVue fMRI
MHRA reference: 2020/003/018/487/004
Philips Respironics: V60 Ventilators
March 2020
Lung ventilators
MHRA reference: 2020/003/016/487/007
Roche Diagnostics: Elecsys CA 19-9
March 2020
IVDs, clinical chemistry
MHRA reference: 2020/001/027/228/009
Siemens: Atellica CH Reaction Cuvette Segment (Update to FSN 20 – 24 January 2020)
March 2020
IVDs, clinical chemistry
MHRA reference: 2020/001/020/601/007
Thermo Fisher Scientific: Oxoid
11 March 2020
IVDs, cacteriology
Model: PB0226A
MHRA reference: 2020/003/012/601/008
Turon MedTech: CYTOGUIDE Needle guide bushes
05 February 2020
Surgical instruments, minimal access
Model: GA12, GA14, GA16, GA18, GA20, GA20 OPEN & GA22
MHRA reference: 2020/003/019/291/004
Ultramed: MyPreOp Kids
12 March 2020
Software as a medical device (SaMD)
MHRA reference: 2020/003/007/401/001
Ultramed: MyPreOp Kids 10.03.2020
12 March 2020
Software as a medical device (SaMD)
MHRA reference: 2020/003/013/487/013
UTAK Laboratories: Normal Range Trace Elements Control
17 March 2020
IVDs, clinical chemistry
MHRA reference: 2020/003/018/701/001
Waldemar Link: Endo-Model Knee Fusion Nail, Femoral, left, Size 1
16 March 2020
Osteosynthesis, nails intramedullary
MHRA reference: 2020/003/017/291/002