Field Safety Notices: 26 to 30 June 2023
List of Field Safety Notices (FSNs) from 26 to 30 June 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
Acumed: 70.0mm Tension Band Kit
22 June 2023
Model: TB-1570K-S, 30-0095K-S
MHRA reference: 5332199
BD: Magic3 Go/Hydrosil Go Intermittent Silicone Catheter
03 May 2023
Single administration urethral drainage catheter
MHRA reference: 5216505
Boston Scientific: IntellaNav StablePoint Ablation Catheter
24 March 2023
Catheter, Cardiac Ablation
MHRA reference: 5132942
BVI: CryoTreQ
21 March 2023
Ophthalmic cryosurgical system, mechanical
MHRA reference: 5324211
Flexicare: BriteBlade Pro
12 June 2023
Laryngoscope Blade, Single Use
MHRA reference: 5327028
Getinge: Rotaflow II drive (flex); Rotaflow II drive (compact)
21 June 2023
Heart-lung bypass System
Model: 701074622
MHRA reference: 5331928
Hamilton Medical: HAMILTON-C1/HAMILTON-T1/HAMILTON-C2/HAMILTON-C3
22 May 2023
MHRA reference: 5241929 2023/005/025/601/043
Integra: Codman Cranial Access Kit without drugs
22 June 2023
Craniotomy Kit
MHRA reference: 5331908 2023/006/023/601/059
Johnson & Johnson Vision: VERITAS Advanced Infusion & Fluidics Packs
14 June 2023
Ultrasonic Surgical System Tubing set
Model: VRT-AI & VRT-AF
MHRA reference: 5332289 2023/006/012/601/044
LifeVac: LifeVac
28 April 2023
Airway Emergency Clearance/ Suction Plunger
MHRA reference: 5216503 2023/005/003/601/013
Medical Measurement Systems: Flowstar
23 February 2023
physiological monitoring. reusable urine flow meter
Model: U2-1
MHRA reference: 5182895
Optergo: Optical Ergonomic Solutions
12 May 2023
MHRA reference: 5241967
Philips: Ingenia Elition, MR 7700
05 June 2023
Magnetic Resonance Imaging (MRI) unit
Model: 781358, 782107, 782119, 782136, 781357, 782106, 782137, 782118, 782132, 782144, 782120, 782130, 782150, 782151
MHRA reference: 5331930
Philips: Patient Information Center iX
26 April 2023
Model: 866389,866390
MHRA reference: 5326968
Philips: IntelliVue MX40 Patient Monitor
FSCA 2023-CC-HPM-014
Model: 865350, 865351, 867146, 865352
MHRA reference: 5323701
QuidelOrtho: Quidel Triage Cardiac Panel
25 May 2023
MHRA reference: 5338144
Randox: LIQUID URINE CONTROL LEVEL 2
28 June 2023
Multiple urine analyte IVD, control
MHRA reference: 5337733
Siemens Healthineers: ARTIS pheno/icono
June 2023
Stationary angiographic x-ray system, digital
MHRA reference: 5332221
ThermoFisher Scientific: EliA GliadinDP IgG Well
Ref: QA2023-03
Gliadin antibody IVD, kit, fluorescent immunoassay
Model: 14-5539-01
MHRA reference: 5228918
UFSK-International OSYS: UFSK-OSYS
27 April 2023
Treatment Chair
Model: 500 XLE
MHRA reference: 5323076
Vela Diagnostics: Sentosa SQ HIV Genotyping Reagents (4x16)
27 June 2023
HIV1 genotyping IVD, kit, nucleic acid technique
MHRA reference: 5332538