Field Safety Notices: 7 to 11 October 2024
List of Field Safety Notices (FSNs) from 7 to 11 October 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
Bactiguard : ZNN™ BACTIGUARD® Bactiguard Implants
26th August 2024
Bone Nail End-Cap
MHRA reference: 31837311 2024/007/031/601/034
Croma: NuVisc Pro
12th September 2024
Model: 37284, 37758
MHRA reference: 32836459 2024/009/006/601/032
Freenome Ltd: EarlyCDT Lung Cancer Test Kit
03 October 2024
Batch Number: ECDTL2-KIT-006 and ECDTL2-KIT-007
Software version: 3.0.2
MHRA reference: 32836536 2024/010/003/601/046
GE Healthcare: Ultrasound system type 2300
FMI 87012
Ultrasound system, Imaging, General purpose
Model: 2300-11(bk3000) and 2300-61(bk5000), 2300-66(bkActiv)
MHRA reference: 32891269 2024/009/023/601/041
Jenx: Ly-on
19th September 2024
MHRA reference: 32821621 2024/009/019/601/023
Merivaara : Merivaara Q-Flow surgical lights
02 October 2024
Operating room light system
Model: Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD,Q-FLOW MOBILE
MHRA reference: 32893660 2024/010/003/601/044
Olympus : OFP 2 Flushing Pump
20th September 2024
Surgical Irrigation Pump
MHRA reference: 32836730 2024/009/017/601/088
Olympus: Outer sheath, 22.5 Fr.
11th October 2024
Cystoscopes, Rigid
Model: WA22810A
MHRA reference: 32877518 2024/010/009/601/037
Philips: Trilogy Evo ,Trilogy Evo O2, Trilogy EV300
9th July 2024
Portable Electric Ventilator
Model: Please refer to Units Affected List
MHRA reference: 32879230 2024/010/010/601/024
SINOVO health solutions GmbH: mylife App
Mylife Diabetes care
GENERAL MEDICINE DIAGNOSIS& MONITORING INSTRUMENTS
Software version: All app versions from v2.1.1 upwards
MHRA reference: 32846979 2024/010/007/601/017
Smith & Nephew, Inc: LEGION OXINIUM Constrained Femorals
02 October 2024
Batch number: 23LM00479 and 23LM03388
MHRA reference: 32843226 2024/010/007/601/082
Smiths Medical: ParaPAC plus™ Model 300 and Model 310 Ventilator
10 October 2024
Portable pneumatic ventilator
Model: 300 and 310
MHRA reference: 32842993 2024/010/007/601/045
MHRA reference: 32842993 - Response form
Stryker: ASSEMBLY, INTERNAL PADDLES, LP15, 3.0
September 2024
Model: Refer to FSN
MHRA reference: 32837892 2024/010/003/601/023