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 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

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

Updates to this page

Published 19 July 2021