Field Safety Notice: 29 July to 2 August 2019

List of field safety notices (FSNs) from medical device manufacturers from 29 July to 2 August 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

Air Liquide: For GMDN code 36289 => MONNNAL T60 and MONNAL T60 JP, For GMDN code 47244 => MONNAL T75 MONNAL T75 JP and MONNAL T75 CO2, For GMDN code 42411 => MONNAL T50, MONNAL T50 DE and MONNAL T50 JP, For GMDN code 36943 => MONNAL T40, MONNAL T40 DE

29 July 2019

Lung ventilators

MHRA reference: 2019/007/029/291/003


29 July 2019

Lung ventilators Monnal T60

MHRA reference: 2019/007/029/291/008


30 July 2019

IVDs, immunology

MHRA reference: 2019/008/001/701/014

Cook Medical: Hemospray Endoscopic Hemostat

July 2019

Haemostatic agents

MHRA reference: 2019/007/022/701/036

Fritz Stephan: SOPHIE

08 July 2019

Lung ventilators

MHRA reference: 2019/007/031/701/001

GE Healthcare: OEC Fluorostar, OEC Fluorostar Compact, OEC Fluorost


X Ray, fluoroscopy systems

MHRA reference: 2019/007/025/487/009

Intersurgical: One-Piece Guedel Airway, Blue, ISO 5.0, Size 00

25 July 2019

Airway devices

MHRA reference: 2019/007/025/487/011

Intuitive Surgical: da Vinci® Xi™ and da Vinci® X™ Surgical System


Endoscopes, rigid

Model: IS4000 Surgical System; IS4200 Surgical System

MHRA reference: 2019/007/025/701/015

KaVo: RONDOflex Powder 27µm 1kg

July 2019

Dental appliances / instruments

MHRA reference: 2019/007/029/291/0077

LeMaitre Vascular: LeMaitre Aortic Occlusion Catheter

26 July 2019

Vascular cannula and catheters

Model: 2107-80

MHRA reference: 2019/007/026/701/013

Medisoft Belgium: FeNO+ FE-00-01

24 June 2019

Diagnostic measurement and monitoring

MHRA reference: 2019/008/001/291/001

Occlutech: Occlutech Delivery Set

24 July 2019

Implants, non-active, cardiac appendage and septal defect occluders / Plugs

MHRA reference: 2019/007/026/487/006

Siemens: IMMULITE/IMMULITE 1000/2000

July 2019

IVDs, clinical chemistry

MHRA reference: 2019/007/015/601/007

Siemens: ADVIA Centaur Folate

July 2019

IVDs, clinical chemistry

MHRA reference: 2019/007/026/601/008

Spectrum: Quantum Pump Console

29 May 2019

Heart lung machines


MHRA reference: 2019/007/012/601/006

The Binding Site: Optilite IgM kit

29 July 2019

IVDs, immunology

Model: NK012.OPT

MHRA reference: 2019/007/029/601/024

Published 5 August 2019