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
Olympus: SnareMaster Plus Hot/Cold
16 October 2025
Endoscopic electrosurgical handpiece/electrode
Model: SD-400U-10, SD-400U-15
MHRA reference: 38087412 2025/010/009/601/065
Philips: Azurion System
05 December 2025 - REF 2025-IGT-BST-013
Stationary angiographic x-ray system, digital
Model: 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236
MHRA reference: 38440576 2025/012/009/601/066
Philips: Azurion System
05 December 2025
MHRA reference: 38440248 2025/012/010/601/013
Philips: Azurion systemBrand
12 December 2025 - REF 2025-IGT-BST-014
Stationary angiographic x-ray system, digital
Model: 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236
MHRA reference: 38443204 2025/012/016/601/080
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
Philips: Allura Xper and Allura CV20
15 December 2025 – REF 2025-IGT-BST-007
MHRA reference: 38443232 2025/012/017/601/105
SYSMEX CORPORATION: TS-10 Automated Tube Sorted
15 December 2025
MHRA reference: 38002838 2025/012/015/601/096
Vascutek: Gelweave, Gelsoft Plus, Thoraflex Hybrid
15 December 2025
Synthetic vascular prostheses, Descending thoracic
Model: All MDR SYGMA (item code ending “E-B”)
MHRA reference: 39097483 2025/012/011/601/044
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