Field Safety Notices - 08 to 12 June 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 08 to 12 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
FSNs before this date are on the National Archives website
BTC Medical Europe Srl: Dispensing kit Clio
27 April 2020
Nuclear medicine
MHRA reference: 2020/005/022/487/003
GE Healthcare: CARESCAPE Patient Data Module
FMI 36146
Monitors, patient
MHRA reference: 2020/006/003/487/008
Groupe SEBBIN: Silicone implants and tissue expanders
27 May 2020
Implants, breast
Model: LS01X, LS02X, LS03X, LS04X, LS05X, LS06, LS07X, LS82X, LS62X, LS89X, LS81X, LS83X
MHRA reference: 2020/006/005/601/007
Groupe Sebbin: Mammary Sizers
26 May 2020
Implants, breast
Model: GABXX
MHRA reference: 2020/006/005/601/008
Lutonix
June 2020
Vascular cannula and catheters
MHRA reference: 2020/006/011/487/007
Medtronic: CareLink Programmer; CareLink Encore Programmer: Update to FSN 09 to 13 March 2020
June 2020
Implants, active, cardiac programmers and remote monitoring
MHRA reference: 2020/003/009/420/004
Medtronic Inc: IN.PACT Admiral™ and IN.PACT Pacific™
15 June 2020
Vascular cannula and catheters
MHRA reference: 2020/006/010/487/004
OCON Medical: IUB Ballerine Intrauterine Device
25 May 2020
Implants, non active, contraceptive implants
Model: IUB Ballerine MID
MHRA reference: 2020/006/001/291/001
PerkinElmer: Vanadis View Plate
11 June 2020
IVDs, immunology
Model: 3224-0010
MHRA reference: 2020/006/011/487/008
Richard Wolf: TUBE SET FOR TEM
05 June 2020
Surgical equipment, miscellaneous
MHRA reference: 2020/006/008/487/003
Siemens: CentraLink(R) Data Management System/Atellica(R) Data Manager
May 2020
IVDs, clinical chemistry
MHRA reference: 2020/006/009/601/001
Verathon Medical: GlideScope® Core OneTouch Cable
05 June 2020
Airway devices
Model: 0600-0772
MHRA reference: 2020/006/001/291/002