Field Safety Notices - 15 to 19 June 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 15 to 19 June 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
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Arcomed: VP7000
01 June 2020
Infusion systems
Model: Chroma, Premium
MHRA reference: 2020/006/015/487/001
Biotronik AG: Passeo-18 Lux
200000375
Vascular cannula and catheters
MHRA reference: 2020/006/010/487/003
Boston Scientific: ELUVIA™ Over-The-Wire (OTW) Drug-Eluting Vascular Stent System
92489879-FA
Vascular cannula and catheters
MHRA reference: 2020/006/010/487/002
Breas: Protective Cover Vivo 55/65
06 February 2020
Lung ventilators
MHRA reference: 2020/002/006/487/014
Datex-Ohmeda (GE Healthcare): Giraffe Omnibed, Giraffe Incubator
FMI 32076
Infant incubators
MHRA reference: 2020/005/019/291/004
Ethicon Endo-Surgery: PERMAHAND™ Silk Suture
16 June 2020
Sutures
MHRA reference: 2020/006/009/487/007
Medtronic: Console IPC-ENT, Master Console EC300, Powerease IPC, Microdebrider M5
June 2020
Surgical power tools
Model: Console:1898001, EC300, 2340000 Handpiece: 1899200
MHRA reference: 2020/006/016/291/002
Natus: Olympic Brainz Monitor
02 March 2020
Monitors, patient
Model: OBM00002
MHRA reference: 2020005/001/601/005
OrthoPediatrics: ACL Reconstruction System - ShieldLoc
06 June 2020
ligaments, tendons and anchors
Model: 10-1008-4060 & 10-1008-4070
MHRA reference: 2020/006/010/701/028
Siemens: Chemistry Calibrator
June 2020
IVDs, clinical chemistry
MHRA reference: 2020/006/012/601/001
Spectranetics: Stellarex - OTW Drug-coated Angioplasty Balloon
D056663
Vascular cannula and catheters
MHRA reference: 2020/006/009/601/005
Teleflex: Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery
18 June 2020
Airway devices
MHRA reference: 2020/006/018/487/011
Wellspect: LoFric Origo, 40cm
16 June 2020
Urinary catheters and accessories
Model: 44310, 44316, 44410, 44414
MHRA reference: 2020/006/016/601/003