Field Safety Notice: 19 to 23 October
List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 October 2020.
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 the 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
3M Health Care: 3M™ Red Dot™ Monitoring Electrode (two variants)
09 October 2020
ECG
MHRA reference: 2020/010/019/487/001
Arjo: Citadel Plus Bariatric Bed Frame System
10 September 2020
Beds and accessories
Model: FXX21A4A4AKFBB, FXX21A4D3AMFBA, FXX21C4B1AAABB, FXX21C4B4ABQBA, FXX21A4C4ACGBB, FXX21A4A1ABUBA, FXX21A6C2ABPBB, FXX21C4B1AAABA, FX811B3B4AMABB, FXX21C4D4AKBBB, FX611A2B2ALVBB
MHRA reference: 2020/007/013/601/002
B Braun: ACTREEN
13 October 2020
Urinary catheters and accessories
Model: 226314E 227416E 228012E 228316E 238112E 239012E 239010E
MHRA reference: 2020/010/013/601/002
Biomet (Zimmer): Scope Procedure Kit with RGX Taper Cap
13 October 2020
Surgical devices, non-powered
Model: ONPOINT SCOPE PROCEDURE KIT - 24-3050; ONPOINT SCOPE PROCEDURE KIT-EU - 24-3055; ARTHROSIMPLICITY KIT EU - 24-4055
MHRA reference: 2020/010/015/487/006
BPR Medical: BPR Medical
20 October 2020
Anaesthetic & breathing, medical gas pipelines
Model: Various
MHRA reference: 2020/010/015/601/010
Jenx: Dreama Slim Support Pads
23 September 2020
Supportive seating
Model: DM36
MHRA reference: 2020/009/029/601/001
Maquet - Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
2020-10-14
MX-8005
Anaesthetic machines & monitors
MHRA reference: 2020/010/020/291/001
Molnlycke Health Care: Mölnlycke® Procedure Trays & Single Packed Shielded Bladed Trocars
01 September 2020
Surgical devices, non-powered
MHRA reference: 2020/010/019/291/001
Murray Health and Beauty: Safe and Sound
16 October 2020
Diagnostic measurement and monitoring
Model: SA8091R
MHRA reference: 2020/010/016/601/002
Omixon Biocomputing: Omixon HLA Twin CE
19 October 2020
IVDs, immunology
Model: SW1
MHRA reference: 2020/010/020/291/005
Respironics California – Philips: V60 ventilator, V60 Plus ventilator
October 2020
Lung ventilators
Model: V60 ventilator
MHRA reference: 2020/010/021/291/008
Siemens: Artis zee, Artis Q and Artis pheno
October 2020
X Ray, fluoroscopy systems
MHRA reference: 2020/010/021/601/007
Signus Medizintechnik: RABEA PEEK
09 October 2020
Spinal implants
Model: Cervical Cage angled 4x12x14mm 5°
MHRA reference: 2020/010/021/601/009
Steripack: Syringe 10 ml with 0,9% sodium chloride
23 October 2020 (An update to FSN 22-26 June 2020)
Vascular cannula/catheter accessories
MHRA reference: 2020/010/012/487/018
Teleflex: Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery
15 October 2020
Airway devices
MHRA reference: 2020/010/022/291/005