Field Safety Notices: 15 - 19 December 2025
List of Field Safety Notices (FSNs) for week 15 - 19 December 2025
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Agfa: DR 800
REF: VR0001207
MHRA reference: 37972568 2025/012/015/601/027
Elekta: Leksell GammaPlan
December 2025
RADIOSURGERY INSTRUMENTS – SOFTWARE
MHRA reference: 37962708 2025/012/012/601/027
Instrumentation Laboratory: HemosIL SynthAFax
18 November 2025
Activated partial thromboplastin
MHRA reference: 38000136 2025/012/016/601/090
Integra LifeSciences: Microsensor /CereLink ICP sensor Basic kit
12 December 2025
Intracranial pressure monitor
MHRA reference: 38023916 2025/012/004/601/048
Intuitive Surgical: ACCESS PORT KIT,WOUND RETRACTOR
16 December 2025
Laparoscopic multi-instrument access port, single-
Model: 430073 and 430075
MHRA reference: 37985172
Philips: Azurion system
12 December 2025
Stationary angiographic x-ray system, digital
Model: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280 ,722281, 722282
MHRA reference: 37984672 2025/012/016/601/111
SYSMEX CORPORATION: TS-10 Automated Tube Sorted
15 December 2025
MHRA reference: 38002838 2025/012/015/601/096
Zimmer Surgical: Zimmer Air Dermatome and Zimmer Dermatome AN
18 December 2025
Dermatome Handpiece, Pneumatic
Model: 00-8801-001-00; 88710100
MHRA reference: 38008530 2025/012/018/601/074