Field Safety Notice: 1 to 5 July 2019

List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 July 2019


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


21 June 2019

Pacemakers, external

M-21 Series (021-001, 021-010, 021-011)

MHRA reference: 2019/007/001/487/002

Biomet (Zimmer): Ultra-Drive® Hose/Drape Assembly and Ultra-Drive® Irrigation Tubing Assembly

27 June 2019

Surgical power tools MHRA reference: 2019/006/028/228/007

Bracco: Day Set III HP

19 June 2019

Media injectors


MHRA reference: 2019/006/028/228/001

Edwards Life Sciences: Edwards CENTERA™ Transcatheter Heart Valve System

FCA 140 Implants, non-active, cardiovascular heart valves 9551S23, 9551S26, 9551S29 MHRA reference: 2019/007/003/291/002

Elekta: Monaco RTP System

June 2019

Radiotherapy planning and verification systems

MHRA reference: 2019/007/004701/024

Grace Medical: Cartilage Microtome System

21 June 2019

IVDs, cytopathology & histopathology

MHRA reference: 2019/007/001/487/001

Grouleff-DK: Stitching Unit

09 May 2019

Trolleys and chairs

Model: G160510 0800-01-019

MHRA reference: 2019/005/013/701/004

Heidelberg Engineering: SPECTRALIS

02 July 2019

Computed tomography

All models.

MHRA reference: 2019/007/002/601/003

Intuitive Surgical: da Vinci® Xi™ EndoWrist® SureForm 60 Reload


Staples and staple guns

48360T-08; 48360G-08

MHRA reference: 2019/006/027/701/008

Medtronic: Medtronic MiniMed Paradigm® Infusion Pumps; Medtronic MiniMed Paradigm® VEOTM; Medtronic MiniMed Infusion Pump

June 2019

Infusion systems

Model: MMT-512, MMT-712, MMT-515, MMT-715, MMT-522,

MMT-722; MMT-554, MMT-754, MMT-508

MHRA reference: 2019/006/028/487/010

Phadia (ThermoFisher): Phadia 1000


IVDs, clinical chemistry


MHRA reference: 2019/007/001/601/003

Roche: Elecsys Anti-CCP. See under "Accessories"

July 2019

IVDs, Immunology

Elecsys Anti-CCP

MHRA reference: 2019/007/004/701/011


06 June 2019

IVDs, immunology

MHRA reference: 2019/006/027/601/002

Published 8 July 2019