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
Medartis: Trilock Screw 14mm, HD7
19 December 2019
Osteosynthesis, Bone Screws
MHRA reference: 2019/012/020/487/001
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
Updates to this page
Last updated 13 October 2022 + show all updates
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Added FSN entry for 'Medartis: Trilock Screw 14mm, HD7' - This was incorrectly missed when this page was originally published.
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First published.