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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Aspire Pharma: Epimax
13 June 2024
Model: Ointment and Paraffin-free Ointment
MHRA reference: 30825025
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
06 June 2024 Ref 24032
Model: C11137
MHRA reference: 30796581
Beckman Coulter: Access HBc Ab
06 June 2024
Model: 34240
MHRA reference: 30796244
bioMérieux: VIDAS FPSA
12 June 2024
Free (unbound) prostate specific antigen(fPSA) IVD
MHRA reference: 30795971
bioMérieux: BIOFIRE BCID2 Panel
12 June 2024 FA-TWD-000005
Bloodstream infection-associates microorganism nuc
Model: RFIT-ASY-0147
MHRA reference: 30796050
DePuy Synthes: Depuy Spine
15 May 2024
MHRA reference: 30816204
Getinge: VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2
2242352-05-21-2024-001-C
Endoscopic Vessel Harvesting Systems
Model: VH-3000, VH-4000
MHRA reference: 30796807
JRI Orthopaedics: Evolution Trial Neck
29 May 2024
Femoral Stem Prosthesis Trial
Model: 126° Standard Offset; 133° Standard Offset; 126° High Offset; 133° High Offset
MHRA reference: 30785801
MERU: Moozi
04 June 2024
MHRA reference: 30744292
Philips: Height Adjustable (HA) FlexTrak Trolley
03 May 2024
Magnetic Resonance Imaging (MRI) unit
Model: 989710006411, 989710006412, 989710008732
MHRA reference: 30469738
Philips: IntelliVue X3 Patient Monitor
Reference # 2023-CC-HPM-045
IntelliVue X3
Model: 867030
MHRA reference: 30807423 FSN
MHRA reference: 30807423 Letter
QuidelOrtho: VITROS Chemistry Products FS Diluent Pack 3
Ref. CL2024-132_EU
Buffered sample dil IVD,auto/semi-automated system
MHRA reference: 30816353
ResMed: Astral 100, Astral 150
18 March 2024
Portable ventilator, electric
Model: 100, 150
MHRA reference: 30826557
Smiths Medical: Bivona Neonatal/Pediatric and Adult Tracheostomy
13 June 2024
Tracheostomy tube, non-reinforced, non-customized
MHRA reference: 30826025
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 SYSTEM
June 2024
HRIS INSTRUMENT CASE/GRAY REV INSTR ACCESSORY CASE
MHRA reference: 30785846