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 OintmentÂ
MHRA reference: ÌýÌýÌýÌý
Beckman Coulter: DxI 9000 Access Immunoassay AnalyzerÂ
06 June 2024 Ref 24032
Model: C11137ÌýÌý
MHRA reference: ÌýÌýÌýÌý
Beckman Coulter: Access HBc AbÌýÌý
06 June 2024
Model: 34240ÌýÌýÂ
MHRA reference: ÌýÌýÌýÌý
bioMérieux: VIDAS FPSA
12 June 2024
Free (unbound) prostate specific antigen(fPSA) IVDÂ
MHRA reference: ÌýÌýÌýÌýÂ
bioMérieux: BIOFIRE BCID2 PanelÌýÌý
12 June 2024 FA-TWD-000005
Bloodstream infection-associates microorganism nucÂ
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: ÌýÌýÌýÌýÂ
JRI Orthopaedics: Evolution Trial NeckÌýÌý
29 May 2024
Femoral Stem Prosthesis TrialÂ
Model: 126° Standard Offset; 133° Standard Offset; 126° High Offset; 133° High OffsetÌýÌý
MHRA reference: ÌýÌýÌýÌý
MERU: Moozi Â
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 X3Â
Model: 867030ÌýÌý
MHRA reference: ¹ó³§±·ÌýÌýÌý
MHRA reference: ³¢±ð³Ù³Ù±ð°ùÌý
QuidelOrtho: VITROS Chemistry Products FS Diluent Pack 3ÌýÌý
Ref. CL2024-132_EUÂ
Buffered sample dil IVD,auto/semi-automated systemÌýÌý
MHRA reference: ÌýÌýÌýÌýÂ
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-customizedÂ
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 attentionÂ
Stryker: HRIS SYSTEMÌýÌý
June 2024
HRIS INSTRUMENT CASE/GRAY REV INSTR ACCESSORY CASEÂ
MHRA reference: