Field Safety Notices: 26th to 30th July 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 26 to 30 July 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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Acutronic: Fabian HFO, +nCPAP, Therapy evolution
21 July 2021
Lung ventilators
Model: 111001, 111001.01, 112001, 113001, 122001, 122012, 121001, 121012
MHRA reference: 2021/007/027/291/006
BioMerieux: VIDAS Anti-HBs Total II
23 July 2021
IVDs, viral microbiology
MHRA reference: 2021/007/026/487/012
Cytophil: Renú Voice 1.5cc
07 February 2021
Implants, reconstructive, body contouring
Model: 08-015-04-VOI
MHRA reference: 2021/007/007/601/001
Drager: Zeus IE and Zeus RS C500
June 2021
Anaesthetic machines & monitors
Model: Zeus IE (MK04000), Zeus RS C500 (MK3000)
MHRA reference: 2021/007/029/291/004
GB (UK) Healthcare: Banana Clip Sling
20 July 2021
Hoists and slings
Model: B-SSPUC-S, B-SSPUC-M, B-SSPUC-L, B-SSPUC-XL
B-SSPUC-M, B-SSPUC-L, B-SSPUC-XL
MHRA reference: 2021/007/016/291/008
Hemosonics: QPlus Cartridges
26 May 2021
Haemostatic agents
Model: KT-0010
MHRA reference: 2021/007/022/000/004
Philips: Trilogy Evo and Trilogy Evo O2
23 July 2021 – 2021-07-A
Lung ventilators
Model: Trilogy Evo: BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IT2110X21B KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
Trilogy Evo O2: DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B EV300: CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
MHRA reference: 2021/007/026/487/009
Philips: Trilogy EV300 and Trilogy Evo O2
23 July 2021 ¬– 2017-07-A
Lung ventilators
Model: Trilogy Evo O2: DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Trilogy EV300: CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
MHRA reference: 2021/007/026/487/009
Philips: Trilogy EV300 and Trilogy Evo O2
23 July 2021 ¬– 2017-07-A
Lung ventilators
Model: Trilogy Evo O2: DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Trilogy EV300: CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
MHRA reference: 2021/007/027/291/015
Welch Allyn: Braun Thermoscan PRO 6000 Ear Thermometer
FA-2021-05-001-SKF-004
Patient temperature measurement
Model: All Models
MHRA reference: 2021/007/028/291/005
Wuxi Nest Biotechnology: Nest Specimen Collection Swab
20 July 2021
IVDs, SARS-CoV-2 PCR test
Model: NSM05
MHRA reference: 2021/007/029/601/002