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Field Safety Notice: 13 to 17 January 2020

Medicines Healthcare Products Regulatory Agency

January 20
12:20 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

Bard Access Systems: BARD Site~Rite 8 Ultrasound System

09 January 2019

Ultrasound, imaging

MHRA reference: 2020/001/007/228/004

BIOMERIEUX: NUCLISENS Lysis Buffer

17 January 2020

IVDs, viral microbiology

MHRA reference: 2020/001/016/487/010

Cardinal Health (Cordis): Cordis POWERFLEX P3 PTA Dilatation Catheter

09 January 2020

Vascular cannula and catheters

MHRA reference: 2020/001/010/291/003

GE Healthcare: 1.5T SIGNA HDxt SIGNAWorks Edition (2019 upgrade for 1.5T SIGNA HDxt systems) - HD28?SIGNA Architect - DV26 (China only)?SIGNA Architect - DV28?SIGNA Pioneer - PX28?SIGNA Premier - RX28

FMI 60961

Magnetic resonance, equipment & accessories

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

GB (UK) Healthcare (Enteral): Enteral-ISOSAF 1ml Low Dose ENFit Single Use Syringe

14 January 2020

Feeding systems and tubes

MHRA reference: 2020/001/014/487/010

Getinge Disinfection AB: Getinge 88-series

CAPA 219071

Cssd wash/clean/drying equipment

Model: 88-5

MHRA reference: 2020/001/014/291/002

Mathys: Affinis Inverse glenosphere 39

14 January 2020

Joint prosthesis, shoulder

Model: 60.30.3039

MHRA reference: 2020/001/015/291/012

Medline Industries: Charger, EU plug

10 January 2020

Surgical equipment, miscellaneous

MHRA reference: 2020/001/014/291/001

Olympus: OLYMPUS EVIS LUCERA PLEURAVIDEOSCOPE

January 2020

Endoscopes, Rrgid

MHRA reference: 2020/001/015/291/001

Radiometer Medical ApS: ABL90 FLEX/FLEX PLUS analyzers

FAN 915-404

IVDs, extra laboratory testing

Model: 393-090/393-092

MHRA reference: 2020/001/016/487/019

Siemens: Ysio Max, Luminos dRF Max, Agile Max, Omnia Max

January 2020

X ray, general

Model: 10762470, 10762471, 10762472, 10762473

MHRA reference: 2020/001/009/601/006

Siemens Healthcare Diagnostics: Atellica IM 1300 and IM 1600 Analyzers

January 2020

IVDs, clinical chemistry

MHRA reference: 2020/001/008/601/004

Siemens Healthcare Diagnostics Inc: Enzymatic Creatinine Rgt

December 2019

IVDs, clinical chemistry

Model: Atellica:11097533, ADVIA: 10335869, Dimension 10471520, Dimension Vista XXXX

MHRA reference: 2020/001/008/601/003

Siemens Healthcare Diagnostics Inc: ADVIA Chemistry Lipase

December 2019

IVDs, clinical chemistry

MHRA reference: 2019/012/031/601/001

Sterisets International: Syringe NaCi 0.9% Luer Lock 20 ml

08 July 2019

Vascular cannula/catheter accessories

Model: Product Ref 14364S

MHRA reference: 2020/001/013/291/001

Teleflex: Rusch Greenlite (MAC 3)

13 January 2020

Airway devices

MHRA reference: 2020/001/014/487/006

Vectura Group: Breelib

September 2018

Nebulizers

Model: 08CD1042, 08CD1050, 08CD1051, 08CD1046

MHRA reference: 2020/001/015/601/001

William Cook: Zenith Alpha Abdominal Endovascular Graft

14 January 2020

Implants, non active, endoprostheses for aortic aneurysms

MHRA reference: 2020/001/015/291/007

Published 20 January 2020

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