Field Safety Notices: 5 to 9 October 2020

List of field safety notices (FSNs) from medical device manufacturers from 5 October to 9 October 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

Acutronic: Fabian HFO Neonatal and pediatric ventilator

5 October 2020

Lung ventilators

MHRA reference: 2020/010/006/487/011

Bausch & Lomb: Dk-line, Okta-line

7 October 2020

Injection devices

MHRA reference: 2020/010/006/487/007

Baxter: PrisMax, V2, ROW TherMax Blood Warmer Unit, ROW

2 October 2020

Dialysis, haemodialysis

Model: 955558, 955515

MHRA reference: 2020/010/005/487/015

Elekta: Elekta Unity

May 2020

Radiotherapy

MHRA reference: 2020/005/006/487/001

Invivo Coporation(Philips): Ingenia 1.5T and 3.0T 16 Channel Shoulder Coil

14 September 2020

Magnetic resonance, equipment & accessories

MHRA reference: 2020/009/024/487/013

Maquet - Getinge: Heater-Cooler Unit HCU 40

2 October 2020

Blood/fluid warming systems

Model: 70104.4054; 70105.4917

MHRA reference: 2020/010/006/487/010

Omnia: Set for Implantology / Surgical Kit

22 September 2020

Surgical instrument procedure pack

MHRA reference: 2020/010/006/487/012

Ortho-Clinical: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG and IgG Control, Calibrator

CL2020-246

IVDs, SARS-CoV-2 Immunoassay (Serology)

Model: 6199920 and 6199921

MHRA reference: 2020/010/006/601/004

Roche Diagnostics: Elecsys CA 19-9

July 2020

IVDs, clinical chemistry

MHRA reference: 2020/007/028/291/001

Siemens: ADVIA Chemistry Fructosamine Reagent

September 2020

IVDs, clinical chemistry

MHRA reference: 2020/009/029/601/004

SLE: SLE4000 and SLE5000

September 2020

Lung ventilators

MHRA reference: 2020/010/006/487/008

Spectranetics (Stryker)

2 October 2020

Vascular cannula and catheters

MHRA reference: 2020/010/006/487/006

Updates to this page

Published 12 October 2020