Field Safety Notices: 10 to 14 March 2025
List of Field Safety Notices from 10 to 14 March 2025.
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
Baxter Medical: TruSystem 7500 surgical table systems
12 March 2025
Field Action Reference: FA-2025-004
Universal operating table, electromechanical
Model: Refer to FSN
MHRA reference: 聽聽 2025/003/012/601/013
BD: 4Fr Single-Lumen PowerPICC Catheters - UPDATED FSN
11 March 2025
REF: MDS-24-5154-B
UPDATE to FSN dated 30th October 2024 -
Peripherally-inserted central venous catheter (SOLO and non-SOLO versions)
Type of Action: Product Removal
Model: Refer to Appendix 1 of FSN
MHRA reference: 聽聽 2024/010/028/601/056
Beckman Coulter: Inhibin B Gen II Reagent
21 February 2025
REF: A81303
LOT/BN: Refer to FSN
MHRA reference: 聽聽 2025/003/007/601/062 - Customer response form
MHRA reference: 聽聽 2025/003/007/601/062 - FSN
Beckman Coulter: IRMA IGF-I
21 February 2025
REF: A15729
INDIVIDUAL AND SPECIFIED HORMONES / PROTEINS
LOT/BN: Refer to FSN
MHRA reference: 聽聽 2025/003/007/601/069 鈥� Customer response form
MHRA reference: 聽聽 2025/003/007/601/069 鈥� FSN
Biosense Webster: VARIPULSE Bi-Directional Ablation Catheters
17.02.2025
Cardiac irreversible electroporation system catheter
Model: Refer to FSN
MHRA reference: 聽聽 2025/002/017/601/049
DiaMed GmbH: Multiple products, see list below
13.03.2025
Bio-Rad Reference: FSCA 002-25
Model: Refer to 鈥淔SCA 002-25 product list_01鈥�
MHRA reference: 聽聽 2025/003/013/601/105
GE HealthCare: MIM Software
GE HealthCare Ref. # 21001
PACS, software
Model: versions 7.2.0 through 7.2.6
MHRA reference: 聽聽 2025/003/011/601/084
Limacorporate S.p.A: Guide for Locking Caps Insertion 鈥� Different sizes
10 March 2025
FSCA number: 20250001
Model: Refer to FSN
MHRA reference: 聽聽 2025/003/011/601/060
Medtronic: MiniMed鈩� Paradigm鈩�, MiniMed鈩� 600 series, and MiniMed鈩� 700 series insulin pump system
February 2025
Medtronic reference: FA1446
Model: Refer to FSN
MHRA reference: 鈥� Diabetes Community letter
MHRA reference: 鈥� Healthcare professional letter聽聽
Medtronic: NIM Vital鈩� Nerve Monitoring System Stimulus Artifact
March 2025
Medtronic Reference: FA1482
Nerve-locating system
Model: Refer to FSN
MHRA reference: 聽聽 2025/003/011/601/024 鈥� Customer ack form
MHRA reference: 聽聽 2025/003/011/601/024 鈥� FSN
Philips: Philips DXR System
07 March 2025
DuraDiagnost, DuraDiagnost Compact
Model: Refer to FSN
MHRA reference: 聽聽 2025/003/011/601/019
Straumann Ltd: TLX/TLX Guided Implant Driver 037.3002
03.03.2025
FSN Ref: ER25-0064
Dental implant holding endpiece, reusable
LOT: GLKJ9 and LGMZ8
MHRA reference: 聽聽 2025/003/006/601/065
Vygon UK Ltd: LIFECATH BIFLUX DOUBLE LUMEN CATHETER
04 March 2025
FSN 鈥� Identifier: 2503/51349/00
Product code: 00229370
Model: Refer to FSN
MHRA reference: 聽聽 2025/003/010/601/077
Zimmer Biomet: Comprehensive庐 Shoulder Primary Stem (5 mm Micro, 6 mm Micro, 7 mm Micro & 7 mm Mini)
13 March 2025
Comprehensive Shoulder System
Model: Refer to FSN
MHRA reference: 聽聽 2025/003/013/601/057