Field Safety Notices: 18 to 22 March 2024
List of Field Safety Notices from 18 to 22 March 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
Abbott: HeartMate 3
March 2024
Heart Ventricle Prosthesis
Model: 106524INT
MHRA reference: 28155002
Agfa: DX-D 100
February 2024
MHRA reference: 28146362
BD: Neonatal ArcticGel Pads for Arctic Sun
16 February 2024
Heating unit, pad, water
MHRA reference: 28602174
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
11 March 2024
Chemiluminescent immunoassay analyzer IVD
Model: C11137
MHRA reference: 28140397
Boston Scientific: Expo 5F Angiographic Catheters
21 March 2024
Catheter, Angiographic
MHRA reference: 28600885
Coloplast: Ureteral Dilator (Ch/Fr 12-14, length 48 cm)
20 March 2024
Endotherapy dilator, single-use
MHRA reference: 28594628
EKF Diagnostic: Quo-Lab A1C Test Kit / PocketChem HbA1Cc Test Kit
04 March 2024
Glycated Haemoglobin Reagent
MHRA reference: 28144631
Getinge: HLS Sets
08 March 2024
Tubing set, heart-lung bypass
MHRA reference: 28140480
Medtronic: Hugo RAS Tower (120VAC/240VAC)
March 2024 FA1373
MHRA reference: 28593428
Medtronic: Hugo RAS Surgeon Console
March 2024 FA1405
MHRA reference: 28593460
Medtronic: Hugo RAS Surgeon Console
March 2024 FA1364
MHRA reference: 28593587
Medtronic: PalindromePrecisionHChronicCatheterKit 23/40 cm
March 2024 FA1403
Double-lumen haemodialysis catheter, implantable
Model: 8888145044CP
MHRA reference: 28144641
MicroPort: XFINE
March 2024
Endocardial pacing lead
Model: XFine JX24D MRI, XFine JX25D MRI, XFine TX25D MRI, XFine TX26D MRI
MHRA reference: 28144629
Miltenyi Biotec: CliniMACS Prodigy TS 310
12 March 2024
Magnetic cell separation system tubing set
MHRA reference: 28138960
Ossenberg: Forearm Crutches
2023-10-RT_UK
MHRA reference: 28602148
Philips: MR systems
12 March 2024
Magnetic Resonance Imaging (MRI) unit
Model: 78104, 78106, 78107, 78108, 781101, 781102, 781103, 781104, 781105, 781106, 781107, 781108, 781145, 781150, 781153, 781170, 781171, 781172, 781173, 781175, 781177, 781178, 781195, 781196, 781253, 781260, 781261, 781262, 781270, 781271, 781277, 781278, 781283, 781295, 781296, 781315, 781341, 781342, 781343, 781344, 781345, 781346, 781347, 781356, 781357, 781358, 781359, 781377, 781396, 781477, 782101, 782103, 782105, 782106, 782107, 782108, 782109, 782110, 782112, 782113, 782115, 782119, 782120, 782129, 782136, 782138, 782139, 782140
MHRA reference: 28598089
Philips: Patient Information Center iX
27 February 2024
Model: 866389,866390,866424
MHRA reference: 28065026
Randox: CYSTATIN C CALIBRATOR (CYSC CAL)
05 February 2024
Cystatin C IVD, calibrator
MHRA reference: 28144657
Stryker: TRIDENT II CLUSTERHOLE HA
March 2024
MHRA reference: 28144258
Swemac: Motec Wrist Arthrodesis
03 March 2024
MHRA reference: 28139008
Thuasne: Custom-made lower-limb orthosis
27 November 2023
MHRA reference: 28144692
Yourgene Health: IONA Nx cfDNA Library Prep Dx Kit
18 March 2024
Multiple congenital aneuploidy screening IVD
MHRA reference: 28150043