Field Safety Notice - 6 August to 10 August
List of field safety notices (FSNs) from medical device manufacturers from 6 August to 10 August
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 FSN
View the latest FSNs
Bausch + Lomb: Stellaris Elite Single Port Vitrectomy Cutters
07 August 2018
Phacoemulsification / vitrectomy systems
MHRA reference: 2018/008/006/291/021
Becton Dickinson: Alaris™ GW800 Pumps & Spares kit
July 2018
Infusion systems
Model: 800TIG2ESD1, 800TIG2GBD1, 800TIG2TRD1 (Pump)
MHRA reference: 2018/008/006/291/001
Biomet (Zimmer-Biomet): Affixus Hip Fracture Nail
31 July 2018
Osteosynthesis, nails intramedullary
MHRA reference: 2018/008/003/701/016
Bovie: Electrosurgical system
18 June 2018
Surgical, diathermy
Model: J-Plasma Precise® 360 Handpiece
MHRA reference: 2018/006/022/601/002
Covidien (Medtronic): BIS™ Vista and BIS™ View Monitoring Systems
August 2018
Monitors, patient
Model: 186-1046, 186-1049, 186-1002-RFB, 186-1001-RFB, 186-0215, 185-0151, 186- 1015,186-1048
MHRA reference: 2018/008/006/291/002
Depuy Synthes: CORAIL® AMT Neck Segments
July 2018
Joint prosthesis, hip
Model: L94003, L94004, L94005, L94006 and L94007
MHRA reference: 2018/005/023/478/016
Eurospine: Cervical locking cage + Lumbar locking cage
RP005/18
Spinal Implants
Model: HRC5SD + A2L9-4S +A2L12-9S + A2L13-13S
MHRA reference: 2018/007/024/291/002
GE: Carestation 620, Carestation 650, Carestation 650c
34093
Anaesthetic machines & monitors
MHRA reference: 2018/008/008/291/001
GE Healthcare: Rotating IV Pole
Ref 32059
Infusion systems
MHRA reference: 2018/008/007/291/006
Implant Direct: simplyRePlant®Implant 4.3mmDx13mmL,4.3mmD platform
HHE 604313U 071918
Implants, dental
Model: 604313U
MHRA reference: 2018/008/003/601/001
Medtronic: MiniMed™ remote controller
August 2018
Infusion systems
Model: MMT-500, MMT-503
MHRA reference: 2018/008/009/291/011
Nuffield Health: surgical procedure packs
03 July 2018
Surgical devices, non-powered
MHRA reference: 2018/008/003/401/016
Siemens: Multix Fusion
01 August 2018
X Ray, digital acquisition systems
Model: 10746665，10746666，10746667 and 10893300
MHRA reference: 2018/008/008/601/004
Thermo Fisher Scientific: Oxoid
08 August 2018
IVDs, bacteriology
Model: PB0308A
MHRA reference: 2018/008/008/601/011
Thread & Lift: Aiguilles réutilisables – Infinite Thread®
03 May 2018
Sutures
Model: aiguille R110, R160, R430, R860
MHRA reference: 2018/008/007/291/007