Field Safety Notices - 27 to 29 May 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 27 to 29 May 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

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Abbott: Alinity c Processing Module

12 May 2020

IVDs, clinical chemistry

MHRA reference:

Draeger: various (all heated breathing circuits)

May 2020

Humidifiers

Model: various

MHRA reference:

Fast Track Diagnostics: FTD Stool parasites

April 2020

IVDs, viral microbiology

Model: Siemens Material Number 10921736 / 10921737

MHRA reference:

Natus: Bedside to Patient Unit Cable (PURU3)

May 2020

Beds and accessories

MHRA reference:

Ortho-Clinical: VITROS庐 3600 Immunodiagnostic System (includes Refurbished systems), VITROS庐 5600 Integrated System (includes Refurbished systems), VITROS庐 XT 7600 Integrated System

CL2020-126

IVDs, clinical chemistry

MHRA reference:

Siemens: IMMULITE 2000 / 2000 XPi Immunoassay systems

May 2020

IVDs, clinical chemistry

MHRA reference:

Smiths Medical: 3.0MM Hyperflex Tracheostomy Uncuffed, Adjust, Nec

18 May

Airway devices

Model: 60HA30

MHRA reference:

Stereotaxis: Niobe ES

04 May 2020

Therapy tissue ablation

Model: 3.2

MHRA reference:

Zimmer Biomet: TiMAX 6.5mm/8.0mm Large Cannulated Screw System

20 May 2020

Orthopaedic surgical instruments - Insertion/extraction tools

MHRA reference:

Updates to this page

Published 1 June 2020