Field Safety Notices: 11 to 16 July 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 16 July 2021.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott: Alinity s System
12 July 2021
IVDs, clinical chemistry
MHRA reference: 2021/007/014/291/003
Beckman Coulter: Kaluza C Flow Cytometry Software
02 July 2021
IVDs, haematology
MHRA reference: 2021/007/007/601/002
Becton Dickinson: Groshong Catheters(Update to FSN 03 to 07 May 2021)
01 July 2021
Vascular cannula and catheters
MHRA reference: 2021/004/030/291/001
Boston Scientific: EMBLEM S-ICD Subcutaneous Electrode (Lead)
15 July 2021
Implants, active, cardiac subcutaneous system
Model: 3501
MHRA reference: 2020/012/003/291/004
CareDx: Olerup QTYPE 11
08 July 2021
IVDs, immunology
MHRA reference: 2021/007/009/487/003
GE Healthcare: Patient Data Module
30 June 2021
Monitors, patient
MHRA reference: 2021/006/029/291/008
Illumina: VeriSeq NIPT Solution v2
04 July 2021
IVD, genetic testing
MHRA reference: 2021/007/009/000/001
Medtronic: Vectris SureScan MRI Lead kit
July 2021
Implants, active, leads, neuro
Model: 977A260, 977A275, 977A290
MHRA reference: 2021/007/009/487/004
Merit Medical: BasixALPHA
24 June 2021
Surgical instruments, minimal access
MHRA reference: 2021/007/009/487/008
Philips Health Systems: V60 Ventilator
V60 Plus Ventilator
July 2021
Lung ventilators
MHRA reference: 2021/007/013/291/006
Stryker: Restoris MCK Femoral Trial
13 July 2021
Joint prosthesis, knee
MHRA reference: 2021/007/012/291/027
Tornier: Aequalis Pyrocarbon Humeral Head
05 July 2021
Joint prosthesis, shoulder
Model: All sizes
MHRA reference: 2021/006/021/000/001
TyTek Medical: TPAK & TPAK10
09 June 2021
Surgical instruments, minimal access
Model: TM 303 & TM 310
MHRA reference: 2021/007/004/701/003
Vapotherm: Oxygen Assist Module (OAM)
09 February 2021
Humidifiers
MHRA reference: 2021/007/005/000/006