Field Safety Notices: 14 to 18 April 2025
List of Field Safety Notices from 14 to 18 April 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 . FSNs before this date are on the
BioFire Diagnostics: BCID2 Panel
7 April 2025
Bloodstream infection-associates microorganism nuc
Model: RFIT-ASY-0147
MHRA reference: 聽聽 2025/004/002/601/083
Cepheid: Xpert BCR/ABL Ultra & Xpert BCR/ABL Ultra p190
3 April 2025
MHRA reference: 聽聽 2025/004/016/601/100聽
Cook Incorporated: Tornado庐 Embolization Microcoil鈩�
17 April 2025
Non-neurovascular embolization coil
Model: MWCE-18S-3/2-TORNADO and MWCE-18S-4/2-TORNADO
MHRA reference: 聽聽 2025/004/015/601/112
GE Healthcare Finland Oy: Centricity High Acuity Anesthesia / Critical Care
FMI 38015
Patient health record information system
MHRA reference: 聽聽 2025/004/015/601/079
Green Power Trading: FASTEST
8 April 2025
Powered Mobility Scooter
MHRA reference: 聽聽 2025/004/015/601/025
MHRA reference: 聽聽 2025/004/015/601/025 鈥� Customer Bulletin
JJGC IND脷STRIA E COM脡RCIO DE MATERIAIS DENT脕RIOS S.A: GM Helix Implant
16 April 2025
Screw Endosteal Dental
Model: GM Helix Acqua Implant,Ti,4.0X11.5
MHRA reference: 聽聽 2025/004/016/601/114
MHRA reference: 聽聽 2025/004/016/601/114 鈥� Customer reply form
Leica Biosystems Melbourne Pty Ltd: HistoCore PELORIS 3
14 April 2025
Tissue processor IVD, automated
Model: 45.0001
MHRA reference: 聽聽 2025/004/013/601/007
Normand-Info SASU: REMISOL Advance
1 April 2025
See Section 8
MHRA reference: 聽聽 2025/004/014/601/098
MHRA reference: 聽聽 2025/004/014/601/098 - Vigilance response form
Philips Medizin Systeme B枚blingen GmbH: Microstream Advance, VitaLine, FilterLine
FSCA-2025-CC-HPM-011
Model: 989803204511 989803204321 989803204301 989803204331 989803204521 989803204531 989803204311 989803204341 989803159571 989803159581 989803160241 989803160251 989803160261 989803182921 989803182931 989803105531 989803105541 989803105561
MHRA reference: 聽聽 2025/004/011/601/011 - FSN
MHRA reference: 聽聽 2025/004/011/601/011 - Letter
Philips: IntelliSpace Cardiovascular
7 April 2025
MHRA reference: 聽聽 2025/004/011/601/007
MHRA reference: 聽聽 2025/004/011/601/007 鈥� Letter and Response form
Remote Diagnostic Technologies Ltd: Tempus Pro
10 April 2025
Transportable physiologic monitoring system
Model: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R
MHRA reference: 聽聽 2025/004/017/601/037聽
Siemens Healthcare Diagnostics Inc: See Comments
April 2025
See Comments
MHRA reference: 聽聽 2025/004/015/601/086聽
Togetherall Ltd: Togetherall
19 March 2025
Model: Not applicable
MHRA reference: 聽聽 2025/004/022/601/999 鈥� Customer reply form
MHRA reference: 2025/004/022/601/999
聽Welch Allyn, Inc: See Comments 鈥淪ection 8鈥�
15 April 2025
See Comments 鈥淪ection 8鈥�
MHRA reference: 聽聽 2025/004/015/601/058