Field Safety Notices - 27 to 29 May 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 27 to 29 May 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
Abbott: Alinity c Processing Module
12 May 2020
IVDs, clinical chemistry
MHRA reference: 2020/005/014/487/003
Draeger: various (all heated breathing circuits)
May 2020
Humidifiers
Model: various
MHRA reference: 2020/005/012/701/014
Fast Track Diagnostics: FTD Stool parasites
April 2020
IVDs, viral microbiology
Model: Siemens Material Number 10921736 / 10921737
MHRA reference: 2020/005/011/291/002
Natus: Bedside to Patient Unit Cable (PURU3)
May 2020
Beds and accessories
MHRA reference: 2020/005/022/487/004
Ortho-Clinical: VITROS® 3600 Immunodiagnostic System (includes Refurbished systems), VITROS® 5600 Integrated System (includes Refurbished systems), VITROS® XT 7600 Integrated System
CL2020-126
IVDs, clinical chemistry
MHRA reference: 2020/005/026/601/003
Siemens: IMMULITE 2000 / 2000 XPi Immunoassay systems
May 2020
IVDs, clinical chemistry
MHRA reference: 2020/005/028/601/008
Smiths Medical: 3.0MM Hyperflex Tracheostomy Uncuffed, Adjust, Nec
18 May
Airway devices
Model: 60HA30
MHRA reference: 2020/005/021/487/003
Stereotaxis: Niobe ES
04 May 2020
Therapy tissue ablation
Model: 3.2
MHRA reference: 2020/005/008/701/035
Zimmer Biomet: TiMAX 6.5mm/8.0mm Large Cannulated Screw System
20 May 2020
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: 2020/005/021/487/002