Field Safety Notices: 23 to 27 August 2021
List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 August
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
View a
View . FSNs before this date are on the
Altomed: Damato Ruthenium Plaque Template
01 August 2021
Radiotherapy, afterloading
Model: A7078
MHRA reference:
A.M.I: i-Cut ICT5011
20 August 2021
Therapy tissue ablation
MHRA reference:
Becton Dickinson: BodyGuard Infusion Pump Systems (Large Volume Infusion Pump Systems)
26 August 2021
Infusion systems
MHRA reference:
Cytocell: Del (5q) Deletion Probe
23 August 2021
IVDs, clinical chemistry
Model: LPH024/LPH024-S
MHRA reference:
Draeger: Atlan A300/ XL, Atlan A350/ XL
August 2021
Anaesthetic machines & monitors
MHRA reference:
GE: CENTRICITY PACS IW WITH UNIVERSAL VIEWER
GEHC ref #85456
Picture archiving and communication system (PACS)
MHRA reference:
Getinge: Heater-Cooler Unit
23 August 2021
Heart lung machines
Model: HCU 40 70104.4054; 70105.4917
MHRA reference:
Getinge: National UK NRP & Edinburgh NRP Perfusion Pack
23 July 2021
Infusion & transfusion, heart lung circuits
MHRA reference:
Iberhospitex: DRENOFAST
09 July 2021
Wound drains
MHRA reference:
Liko: OctoStretch with Stretch Leveller, FlexoStretch, Stretch Leveller, LikoStretch 1900, LikoStretch Mod 600 IC
FA 2021-05-002-LUL-003
Hoists and slings
Model: 3156056, 3156057, 3156200, 3156051, 3156065, 3156065B
MHRA reference:
Medtronic: DLP Left Heart Vent
August 2021
Infusion & transfusion, heart lung circuits
Model: 12116, 12118
MHRA reference:
Paradigm Spine: Siehe Anhang 1: REC 2021-02
06 August 2021
Osteosynthesis, bone screws
MHRA reference:
Philips: Infant/Child SMART Pads Cartridges
August 2021
Defibrillators, non implantable
Model: M5072A
MHRA reference:
Smiths: Bivona Microlaryngeal Endotracheal Tube
16 August 2021/3012307300-08/09/2021-011-R
Airway devices
Model: 35W025, 25W080, 35W030, 25W085, 35W035, 25W090, 35W040
MHRA reference:
Thermo Fisher: Oxoid
18 August 2021
IVDs, bacteriology
Model: SR0047C
MHRA reference:
Welch Allyn: ELI280 MLBUR280 BUR280
2021-07-001-MKE-005
Electrophysiology Measurement
MHRA reference: