Field Safety Notices: 7 to 11 September 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 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

Across: Revolax, Dermalax, dermaren

1 September 2020

Implants, reconstructive, body contouring

MHRA reference 2020/008/031/601/001

Advanced Medical Solutions: ACTIVHEAL Hydrogel

02 September 2020

Haemostatic agents

Model: 10014007

MHRA reference 2020/008/011/601/008

Armstrong Medical: Catheter Mounts

10 September 2020

Breathing system components

MHRA reference: 2020/008/018/487/011

Caesarea Medical Electronics: T34 Ambulatory Syringe Pump

07 September 2020

Infusion systems

MHRA reference: 2020/009/008/487/001

Getinge - MAQUET: mobile OR-Table MEERA, YUNO und YUNO II

2020-09-08

2020-010

Operating table

Model: 720001B2, 720001B0, 720001F2, 720001F0, 710001B2, 710001B0, 143301B0, 143301F0, 143302B0, 143302F0

MHRA reference: 2020/009/009/701/026

ICU Medical: Spiros

08 September 2020

Infusion & transfusion, connectors

MHRA reference: 2020/009/004/701/026

Lifemax UK: Hearing aid

4 September 2020

Disabled peoples’ aids

MHRA reference: 2019/011/006/291/003

Medtronic: Rashkind® Balloon Septostomy Catheters

September 2020

Vascular cannula and catheters

Model: 007160, 007161, 008764

MHRA reference: 2020/009/010/487/004

Micro Therapeutics (Medtronic): PipelineTM Flex Embolization Device (with Shield TechnologyTM)

September 2020

Intracranial flow diverters / stents

Model: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX, PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-475-XX, PED2-500-XX

MHRA reference: 2020/009008/487/002

Nouvag AG: MD11 / MD30

11 August 2020

Dental, laboratory equipment

MHRA reference: 2020/009/009/487/007

Olympus: OES CHOLEDOCHOFIBERSCOPE - OLYMPUS CHF TYPE CB30S

September 2020

Endoscopes, flexible

Model: CHF-CB30S

MHRA reference: 2020/009/010/291/001

Philips: Efficia DFM 100

11 August 2020

Defibrillators, non-Implantable

Model: 866199

MHRA reference: 2020/009/004/291/006

Pressalit A/S: VALUE II

08 September 2020

Bath and aids

Model: R1610

MHRA reference: 2020/009/009/601/003

Siemens: ADVIA Centaur HER-2/neu (H2n) Assay and ADVIA Centaur

August 2020

IVDs, clinical chemistry

MHRA reference: 2020/009/003/601/009

Thermo Fisher: Oxoid

03 September 2020

IVDs, bacteriology

Model: CT0034B

MHRA reference: 2020/009/004/601/006

Vascular Solutions (Teleflex)

08 September 2020

Vascular cannula and catheters

Model: 5515; 5540; 5545; 5550

MHRA reference: 2020/009/010/701/012

Updates to this page

Published 14 September 2020