Field Safety Notices: 6 to 10 March 2023
List of Field Safety Notices (FSNs) from 6 to 10 March 2023
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
Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App/ HCP Resolution Letter FSLL Resolved FSL3 Pending
23 February 2023
Invasive Interstitial-fluid glucose monitoring system
MHRA reference: 5099927
Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / Customer Resolution Letter Signal Loss Resolution FSL3
25 February 2023
Invasive Interstitial-fluid glucose monitoring system
MHRA reference: 5099927
Abbott: FreeStyle LibreLink App, FreeStyle Libre 3 App / HCP Resolution Letter Signal Loss Resolution FSL3
25 February 2023
Invasive Interstitial-fluid glucose monitoring system
MHRA reference: 5099927
Armstrong Medical: Neonatal Breathing Circuits
03 March 2023
Aquavent Neo Heated Ventilator Circuits, NeoFlow Humidified Oxygen Systems, Aquavent Neo nCPAP Systems
MHRA reference: 5099946
B Braun: CAIMAN
08 March 2023
Endoscopic electrosurgical handpiece
Model: PL770SU, PL771SU, PL774SU, PL775SU
MHRA reference: 5100203
Boston Scientific: Habib EndoHPB Bipolar Radiofrequency Catheter
02 March 2023
Endoscopic electrosurgical handpiece/electrode
MHRA reference: 5097885
Brainlab: ExacTrac Dynamic
25 January 2023
Radiation therapy software
Model: 20910-01E, 20910-01F
MHRA reference: 5100531
Draeger: Flex ventilation hoses
January 2023
Tubing
MHRA reference: 5097923
Eakin Surgical: Diathermy Suction
16 February 2023
Endoscopic electrosurgical handpiece/electrode
MHRA reference: 5099868
Elekta: Monaco RTP System
February 2023
Radiation therapy application software
MHRA reference: 5093513
Inpeco: Accelerator a3600
10th March 2023
Specimen processing instrument IVD, automated
MHRA reference: 32844651 2024/009/019/601/024
GE Healthcare: Vivid i, Vivid q, Vivid S5, Vivid S6
GEHC Ref# 76194
Ultrasound system, imaging, cardiovascular
MHRA reference: 5097827
Macopharma: Single or multiple blood bag with LCRD2 filter
08 March 2023
In-line red cell filtration system
MHRA reference: 5099933
Medex: Qitexio – 20ml Luer Lock Syringe
28 February 2023
General purpose syringe, single-use
MHRA reference: 5100572
Objective Imaging: Glissando
08 March 2023
Cell morphology analyser IVD, automated
Model: Objective Imaging Desktop Scanner
MHRA reference: 5100586
Philips: Tempus Pro Patient Monitor
15 February 2023
Transportable system
Model: 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, 00-1026-R
MHRA reference: 5099402
Philips: DigitalDiagnost C50 1.0 & 1.1
27 February 2023
Model: 712201, 712204
MHRA reference: 5100634
ThermoFisher Scientific: RAPID Hp StAR Kit
10 March 2023
MHRA reference: 5100641
Winnomed: 1L Latex-Free Breathing Bag and 2L Latex-Free Breathing Bag
17 February 2023
Model: 040201, 040202
MHRA reference: 5099324