Field Safety Notices: 10 to 14 June 2024

List of Field Safety Notices from 10 to 14 June 2024.

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

Aspire Pharma: Epimax

13 June 2024

Model: Ointment and Paraffin-free Ointment 

MHRA reference: ÌýÌýÌýÌý

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 

06 June 2024 Ref 24032

Model: C11137ÌýÌý

MHRA reference: ÌýÌýÌýÌý

Beckman Coulter: Access HBc AbÌýÌý

06 June 2024

Model: 34240ÌýÌý 

MHRA reference: ÌýÌýÌýÌý

bioMérieux: VIDAS FPSA

12 June 2024

Free (unbound) prostate specific antigen(fPSA) IVD 

MHRA reference: ÌýÌýÌýÌý 

bioMérieux: BIOFIRE BCID2 PanelÌýÌý

12 June 2024 FA-TWD-000005

Bloodstream infection-associates microorganism nuc 

Model: RFIT-ASY-0147

MHRA reference: ÌýÌýÌýÌý

DePuy Synthes: Depuy Spine

15 May 2024

MHRA reference: ÌýÌýÌýÌý

Getinge: VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2ÌýÌý

2242352-05-21-2024-001-°äÌý

Endoscopic Vessel Harvesting SystemsÌýÌý

Model: VH-3000, VH-4000 ÌýÌý

MHRA reference: ÌýÌýÌýÌý 

JRI Orthopaedics: Evolution Trial NeckÌýÌý

29 May 2024

Femoral Stem Prosthesis Trial 

Model: 126° Standard Offset; 133° Standard Offset; 126° High Offset; 133° High OffsetÌýÌý

MHRA reference: ÌýÌýÌýÌý

MERU: Moozi   

04 June 2024

MHRA reference: ÌýÌýÌýÌý

Philips: Height Adjustable (HA) FlexTrak TrolleyÌýÌý

03 May 2024

Magnetic Resonance Imaging (MRI) unitÌýÌý

Model: 989710006411, 989710006412, 989710008732

MHRA reference: ÌýÌýÌýÌý

Philips: IntelliVue X3 Patient Monitor

Reference # 2023-CC-HPM-045

IntelliVue X3 

Model: 867030ÌýÌý

MHRA reference: ¹ó³§±·ÌýÌýÌý

MHRA reference: ³¢±ð³Ù³Ù±ð°ùÌý

QuidelOrtho: VITROS Chemistry Products FS Diluent Pack 3ÌýÌý

Ref. CL2024-132_EU 

Buffered sample dil IVD,auto/semi-automated systemÌýÌý

MHRA reference: ÌýÌýÌýÌý 

ResMed: Astral 100, Astral 150ÌýÌý

18 March 2024

Portable ventilator, electricÌýÌý

Model: 100, 150

MHRA reference:

Smiths Medical: Bivona Neonatal/Pediatric and Adult TracheostomyÌýÌý

13 June 2024

Tracheostomy tube, non-reinforced, non-customized 

MHRA reference: ÌýÌý

This FSN dated the 13th June is duplicated, from the FSN listing page for 27 to 31 May, for your information and attention 

Stryker: HRIS SYSTEMÌýÌý

June 2024

HRIS INSTRUMENT CASE/GRAY REV INSTR ACCESSORY CASE 

MHRA reference:

Updates to this page

Published 21 June 2024