Field Safety Notices: 04 to 08 January 2021
List of field safety notices (FSNs) from medical device manufacturers from 04 January to 08 January 2021
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.
Baxter: Artis, Evosys, Integra, Innova
27 November 2020
Dialysis, haemodialysis
Model: ARTIS 230V 110635, EVOSYS 230V 110648 ARTIS AFBK 114389, ARTIS 230 PHYSIO 115323 ARTIS 230 PHYSIO LP 115324, ARTIS AFBK PHYSIO 115326 ARTIS 230V LP 115401, ARTIS 230V PHYSIO I 115962 ARTIS 230V PHYSIO II 955412, ARTIS 230V PHYSIO II LP 115964 ARTIS AFBK PHYSIO II 115966, ARTIS 230V PYSIO PLUS 955680 ARTIS 230 PHYSIO PLUS LP 955681, ARTIS AFBK PHYSIO PLUS 955683 INNOVA 230V DIACARD 101323, INNOVA 230 106911 INTEGRA EU/HDF AP 100319, INTEGRA EU/AP 103450 INTEGRA EU/DIACARD 101324, INTEGRA 106910
MHRA reference: 2020/011/026/291/003
Baxter: Cartridge Single Needle, Artiset HD DNL HC, Artiset Prepost, Cartridge with Hemoscan, Artiset HD SN HC, Cartridge Extended Patient Lines, Cartridge Ext/ Patient Lines + Infusion, Cartridge Standard, Cartridge Low Weight, Cartridge Low Weight Low Volume, Physioset HD DNL HC, Physioset Prepost
08 January 2021
Dialysis, blood lines
MHRA reference: 2021/001/007/487/002
Carl Zeiss Meditec: Zeiss
FSCA 2020-007
Ophthalmology equipment
Model: IOL Master 700
MHRA reference: 2020/012/007/601/002
Ellex Medical Pty: Tango, Solo, Super Q, Ultra Q
03 April 2020
Therapy, Lasers
Model: LT5106-T/S,LQP3106,LQP3106-U
MHRA reference: 2020/004/015/601/002
GE Medical Systems: Discovery NM 630, Optima NM/CT 640, Discovery NM/CT 670 DR, Discovery NM/CT 670 Pro, Discovery NM/CT 670 ES, NM 830, NM 830 DoD, NM/CT 850, NM/CT 860, NM/CT 870 CZT, NM/CT 870 DR
04 January 2021
SPECT-ct
MHRA reference: 2021/001/004/291/003
Leica Biosystems: Novocastra™ Liquid Mouse Monoclonal Antibody N-Cadherin
14 December 2020
Novocastra™ liquid mouse monoclonal antibody n-cadherin
MHRA reference: 2020/012/014/601/007
Microbiologics: KWIK-STIK-LYFO-DISK™ 0894 Microsporum canis /5249P
December 2020
IVDs, bacteriology
Model: Microsporum canis derived from ATCC® 36299™
MHRA reference: 2021/001/004/291/001
Schiller: Tempus LS
25 November 2020
Defibrillators, non Implantable
Model: 1A.702100
MHRA reference: 2021/001/004/291/002
Terumo BCT: Spectra Optia Apheresis System
December 2020
Apheresis
MHRA reference: 2021/001/007/487/001