Field Safety Notice: 23 to 27 December 2019

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 December 2019.

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

GE: Carestation 600 Series

FMI 34104

Anaesthetic machines & monitors

MHRA reference: 2019/012/020/291/008

Intuitive Surgical: 8 mm Endoscope and Camera Head Sterilization Tray

ISIFA2019-10-C

Surgical devices, non-powered

Model: 400498-02, 400499-03

MHRA reference: 2019/012/018/701/056

Philips Healthcare: OmniDiagnost Eleva

20 December 2019

X Ray, fluoroscopy systems

Model: 708027, 708032, 708034, 708036, 708037, 708038, 722001, 722003, 722005, 722006, 722008,722010, 722011, 722012, 722013, 722014, 722015, 722020, 722023, 722026, 722027, 722028, 722029, 722030, 722031, 722035, 722038, 722039, 722058 and 722400

MHRA reference: 2019/012/024/487/003

Philips Healthcare 2018-IGTBST-015: OmniDiagnost Eleva

20 December 2019

X Ray, fluoroscopy systems

Model: 708027, 708032, 708034, 708036, 708037, 708038, 722001, 722003, 722005, 722006, 722008,722010, 722011, 722012, 722013, 722014, 722015, 722020, 722023, 722026, 722027, 722028, 722029, 722030, 722031, 722035, 722038, 722039, 722058 and 722400.

MHRA reference: 2019/012/024/487/004

Philips Medical FCO 7900045: CombiDiagnost R90

25 November 2019

X ray, fluoroscopy systems

Model: 709030

MHRA reference: 2019/012/020/291/030

Philips Medical Systems FCO 70900048: CombiDiagnost R90

25 November 2019

X ray, fluoroscopy systems

Model: 709030

MHRA reference: 2019/012/020/291/017

RaySearch Laboratories AB: RayStation 4.0, RayStation 4.3 (InverseArc), RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation/RayPlan 7, RayStation/RayPlan 8A, RayStation/RayPlan 8B and RayStation/RayPlan 9A

18 December 2019

Radiotherapy planning and verification systems

MHRA reference: 2019/012/020/291/002

Published 30 December 2019