Field Safety Notices: 30 October to 3 November 2023
List of Field Safety Notices from 30 October to 3 November 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: Alinity s System
19 October 2023
Chemiluminescent immunoassay analyser IVD
MHRA reference: 27512962
Abbott: Alinity m HCV AMP Kit
30 October 2023
Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
MHRA reference: 27520217
Baxter: EVO IQ Syringe Pump
17 October 2023
Model: ESYR001GRC (non UK) and ESYR001UKI (UK)
MHRA reference: 27512180
Beckman Coulter: Access 2 Immunoassay Analyzer (81600N); Access 2 Immunoassay Analyzer, Refurbished (386220); Access 2 Immunoassay Analyzer-Refurbished (A65531); and Access 2 Section, DxC 600i Packaged (A25640)
30 January 2023
Chemiluminescent immunoassay analyser IVD
MHRA reference: 5143098
bioMérieux: BCID2 Panel
02 November 2023
Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
Model: RFIT-ASY-0147
MHRA reference: 27515932
Eitan Medical: Sapphire Multi-Therapy and Sapphire Epidural
12 September 2023
MHRA reference: 27515954
Elekta: Unity
June 2023
SINGLE ENERGY LINEAR ACCELERATORS
Model: 1553106
MHRA reference: 27512490 update to 5145650
Medtronic: HVAD Pump Implant Kit
October 2023 FA1372
Implantable Ventricular Circulatory Assist System
MHRA reference: 27516083
Philips: Allura Xper, Allura Centron, and Azurion systems
15 August 2023
Interventional Fluoroscopic X-Ray System
Model: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400
MHRA reference: 27515072
Philips: MD Eleva systems
15 August 2023
Interventional Fluoroscopic X-Ray System
Model: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400
MHRA reference: 27515072
Philips: Intera, Achieva, Ingenia CX
23 October 2023
Magnetic Resonance Imaging (MRI) unit
Model: 781105, 781195, 781295, 781178, 781196, 781296, 781343, 781283, 781346, 781261, 781262, 781260, 782112
MHRA reference: 27503910
Stryker: Power-PRO 2® components - potential reduced material strength – Scope Expansion
October 2023
Ambulance Stretcher, Electrohydraulic
Model: 6507
MHRA reference: 27480883 Updated FSN dated Oct 2023