Field Safety Notice: 23 to 27 September

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 September 2019.

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.

Abbott: Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module

11 September 2019

IVDs, haematology

MHRA reference: 2019/009/016/701/003

Biomet (Zimmer): Various Biomet Products

25 September 2019

Joint prosthesis, hip

MHRA reference: 2019/009/026/487/001

Bruin Biometrics: SEM Scanner 200

1 September 2019

Diagnostic measurement and monitoring

200

MHRA reference: 2019/009/012/701/005

Convatec: Convex Two-Piece Skin Barriers i.e. Natura /Surfi

20 September 2019

Ostomy and continence equipment

MHRA reference: 2019/008/028/701/002

CooperSurgical: Embryology Heated Plate within the RI WitnessTM

19 August 2019

Laboratory equipment associated with IVF, cells, tissues

6-70-807; 6-70-807-A; 6-70-807-B

MHRA reference: 2019/009/023/487/002

Elekta: MOSAIQ®

September 2019

Radiotherapy

MHRA reference: 2019/009/025/701/017

FIM MEDICAL: VT1

1705

Optical, ophthalmic instruments & equipment

MHRA reference: 2019/009/024/487/001

GE: Achilles Express, Achilles Insight

GEHC Ref# 14019

Bone densitometry

MHRA reference: 2019/009/026/487/026

GN: Resound; Beltone

16 September 2019

Disabled peoples’ aids

Resound; Beltone

MHRA reference: 2019/009/024/487/002

Herida Healthcare: Herida Healthcare Lothian II Dynamic Mattress System

03 September 2019

Mattresses - active/passive and overlay

Lothian II Dynamic Mattress System (Product Code: LOTH-121)

MHRA reference: 2019/009/016/601/003

Hyphen BioMed: BIOPHENTM Normal Control Plasma

19 September 2019

IVDs, clinical chemistry

MHRA reference: 2019/009/025/487/025

12 September 2019

Monitors, patient

826820

MHRA reference: 2019/009/026/487/004

LivaNova: VNS Therapy® SenTiva® Generator (Recall and Patient Management Recommendations Attached)

26 September 2019

Implants, active, stimulators, neuro

1000

MHRA reference: 2019/009/026/487/021

September 2019

Implants, active, pacemakers

2090, 29901

MHRA reference: 2018/010/012/291/013

Novarad: NovaPACS

23 September 2019

Picture Archiving and Communication System (PACS)

MHRA reference: 2019/009/025/701/016

Philips: V60

30 August 2019

Lung ventilators

MHRA reference: 2019/009/023/487/037

Philips Health: Forte, Forte Jetstream AZ, Forte Jetstream, Diamond Select Forte, Diamond Select Forte

JETStream

19 September 2019

Nuclear medicine

Model: 882020 Forte, 882320 Forte Jetstream AZ, 882321 Forte Jetstream AZ upgrade, 882290 Forte Jetstream, 882291 Forte Jetstream upgrade, 889456 Diamond Select Forte, 889471 Diamond Select Forte JETStream

MHRA reference: 2019/009/024/487/035

Randox Laboratories: NEFA

23 September 2019

IVDs, clinical chemistry

FA115

MHRA reference: 2019/009/023/601/002

Roche Diagnostics: HCYS (Homocysteine Enzymatic Assay)

September 2019

IVDs, clinical chemistry

MHRA reference: 2019/009/024/701/009

Smith & Nephew Medical: RT-plus modular femoral block

19 September 2019

Joint prosthesis, knee

MHRA reference: 2019/009/019/701/020

Spacelabs: Xhibit Central Station

30 August 2019

Monitors, patient

Model 96102

MHRA reference: 2019/009/023/487/039

Tem Innovations (Instrumentation Laboratory): r ex-tem

22 July 2019

Assay/ reagent

MHRA reference: 2019/009/023/487/036

Updates to this page

Published 1 October 2019