Field Safety Notice - 22 October to 26 October
List of field safety notices (FSNs) from medical device manufacturers from 22 October to 26 October
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: Ichem Velocity Urine Chemistry Strips
23 October 2018
IVDs, clinical chemistry
MHRA reference: 2018/010/024/601/004
Biomerieux: VITEK® 2 AST-ST01, ST02, ST03
18 October 2018
VDs, bacteriology
MHRA reference: 2018/010/022/487/001
Carl Zeiss: Operating Table
16 October 2018
Operating table
Model: PLEX Elite 9000
MHRA reference: 2018/010/024/601/001
Fannin: Brazier’s CCEY Agar
19 October 2018
IVDs, bacteriology
MHRA reference: 2018/010/019/601/002
GE Healthcare: Dash 3000/4000/5000, Solar 8000M/i, Solar 9500
GEHC Ref 36131
Monitors, patient
MHRA reference: 2018/010/022/291/002
Herbert Waldmann: UV Therapy System UV 7001
05 October 2018
Therapy, UV therapy system
MHRA reference: 2018/010/024/291/002
Intuitive Surgical: da Vinci® EndoWrist® Monopolar Curved Scissors
ISIFA2018-14-C
Surgical, diathermy
Model: 470179-17 ; 470179-18 ; 420179-20
MHRA reference: 2018/010/025/701/040
LivaNova: Heater-cooler (1T), Heater-cooler 3T
October 2018
Blood/fluid warming systems
MHRA reference: 2018/010/023/291/004
Magstim: Neurosign V4 Trolley
19 October 2018
Stimulators diagnostic
Model: 4230-00
MHRA reference: 2018/010/022/487/027
Medical Device Safety Service (ICU Medical): THERMOSET® Closed-Loop Injectable Delivery system
16 October 2018
Infusion & transfusion, administration sets
Model: 011-41423-03 and 011-41424-03
MHRA reference: 2018/010/018/701/025
Medtronic: Synergy Cranial, StealthStation Cranial
October 2018
Synergy cranial, stealthStation cranial
Model: 9733763, 9735585
MHRA reference: 2018/010/022/487/022
Ortho Clinical Diagnostics: VITROS 5,1FS, 3600, 4600, 5600 & XT7600 instruments
October 2018
IVDs, clinical chemistry
MHRA reference: 2018/010/023/601/008
Philips Medical System (HeartStart): Philips HeartStart FR3 AED
10 October 2018
Defibrillators, non implantable
Model: 861388, 861389
MHRA reference: 2018/010/023/487/003
Philips Medical Systems: System, X-ray, Stationary
10 September 2018
X Ray, digital acquisition systems
Model: 712027, 712028, 712029, 712031, 712032, 712033, 712224, 712225, 712226, 712227, 712228
MHRA reference: 2018/010/018/291/003
Siemens (Artis): Artis Pheno
06 September 2018
X Ray, fluoroscopy systems
MHRA reference: 2018/010/025/601/002
Siemens (Vista): Dimension Vista Intelligent Lab System
October 2018
IVDs, clinical chemistry
MHRA reference: 2018/010/022/601/007
Stephanix: X-ray Remote Controlled System
15 October 2018
X Ray, digital acquisition systems
Model: D2RS, DX-D800, VISIONARY DRF
MHRA reference: 2018/010/019/701/022
The Binding Site: Human IgM Kit for use on SPAPLUS
15 October 2018
IVDs, immunology
Model: NK012.S
MHRA reference: 2018/010/024/601/005