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 . FSNs before this date are on the
Abbott: HeartMate 3聽聽
March 2024
Heart Ventricle Prosthesis
Model: 106524INT聽
MHRA reference: 听听听听
Agfa: DX-D 100聽
February 2024
MHRA reference: 听听听听聽聽
BD: Neonatal ArcticGel Pads for Arctic Sun聽
16 February 2024
Heating unit, pad, water聽
MHRA reference: 听听听听听听听听
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
11 March 2024
Chemiluminescent immunoassay analyzer IVD聽
Model: C11137
MHRA reference: 听听听听
Boston Scientific: Expo 5F Angiographic Catheters聽
21 March 2024
Catheter, Angiographic聽
MHRA reference: 听听听听
Coloplast: Ureteral Dilator (Ch/Fr 12-14, length 48 cm)聽
20 March 2024
Endotherapy dilator, single-use
MHRA reference: 听听听听 听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听听聽
EKF Diagnostic: Quo-Lab A1C Test Kit / PocketChem HbA1Cc Test Kit聽
04 March 2024
Glycated Haemoglobin Reagent聽
MHRA reference: 听听听听聽
Getinge: HLS Sets聽
08 March 2024
Tubing set, heart-lung bypass聽
MHRA reference: 听听听听
Medtronic: Hugo RAS Tower (120VAC/240VAC)
March 2024 FA1373
MHRA reference: 听听听听
Medtronic: Hugo RAS Surgeon Console
March 2024 FA1405
MHRA reference: 听听听听
Medtronic: Hugo RAS Surgeon Console
March 2024 FA1364
MHRA reference: 听听听听
Medtronic: PalindromePrecisionHChronicCatheterKit 23/40 cm
March 2024 FA1403
Double-lumen haemodialysis catheter, implantable
Model: 8888145044CP聽
MHRA reference: 听听听听
MicroPort: XFINE
March 2024
Endocardial pacing lead聽
Model: XFine JX24D MRI, XFine JX25D MRI, XFine TX25D MRI, XFine TX26D MRI
MHRA reference: 听听听听
Miltenyi Biotec: CliniMACS Prodigy TS 310聽聽
12 March 2024
Magnetic cell separation system tubing set聽
MHRA reference: 听听听听
Ossenberg: Forearm Crutches
2023-10-搁罢冲鲍碍听听
MHRA reference: 听听听听
Philips: MR systems
12 March 2024
Magnetic Resonance Imaging (MRI) unit聽
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: 听听听听
Philips: Patient Information Center iX聽聽
27 February 2024
Model: 866389,866390,866424聽聽
MHRA reference: 听听听听聽
Randox: CYSTATIN C CALIBRATOR (CYSC CAL)聽
05 February 2024 聽
Cystatin C IVD, calibrator聽
MHRA reference: 听听听听
Stryker: TRIDENT II CLUSTERHOLE HA聽聽
March 2024
MHRA reference: 听听听听听听听听聽
Swemac: Motec Wrist Arthrodesis聽
03 March 2024
MHRA reference: 听听听听
Thuasne: Custom-made lower-limb orthosis
27 November 2023
MHRA reference: 听听听听聽
Yourgene Health: IONA Nx cfDNA Library Prep Dx Kit聽
18 March 2024
Multiple congenital aneuploidy screening IVD聽
MHRA reference: