Field Safety Notice: 9 to 13 November 2020
List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 November 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
ALCIS: ALBAFLEX dental arch
2 November 2020
Dental appliances / instruments
Model: 2099-AN
MHRA reference: 2020/011/009/487/001
Becton Dickinson: Alaris™ GP and GP Guardrails, Alaris™ neXus GP
10 November 2020
Infusion systems
MHRA reference: 2020/011/006/291/001
Cardinal Health: Protexis Latex Micro Surgical Gloves
October 2020
Gloves, surgical & examination
MHRA reference: 2020/010/023/701/006
GE Healthcare: 2030360-001
GEHC Ref# 30097
ECG
MHRA reference: 2020/011/012/487/004
Kunshan Aoshida Electric Technology: Freedom Chair
2 September 2020
Wheelchairs, powered
Model: A06L
MHRA reference: 2020/004/017/601/007
Microbiologics: KWIK-STIK™ 2or6 Pack 01145 /QC Sets & Panels 5226P
05 October 2020
IVDs, bacteriology
Model: Catalog 01145P Klebsiella pneumoniae derived from NCTC
MHRA reference: 2020/011/005/291/001
Philips: Philips-EPIQ and Affiniti Ultrasound system
27 October 2020
Ultrasound, imaging
Model: EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx Affiniti 30, Affiniti 50 and Affiniti 70
Soft
ware version number (if applicable)
Software versions affected worldwide: 1.0.x, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.7.x, 1.8.x, 2.0.x, 3.0.x, 4.0.x, 5.0, 5.0.1.
Software versions affected China only: 1.0.x, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.7.x, 1.8.x, 1.9.x, 2.1.x.
MHRA reference: 2020/011/005/291/005
SD Biosensor: Total 7 products including SARS-CoV-2 Rapid Antigen Test
09 November 2020
IVDs, SARS-CoV-2 PCR Test
MHRA reference: 2020/011/009/601/006
Stereotaxis: Niobe ES
28 October 2020
Surgical navigation system and accessories
Model: 3.2
MHRA reference: 2020/010/013/701/008
Stryker: Mako Integrated Cutting System (MICS)
5 November 2020
Surgical power tools
MHRA reference: 2020/011/004/291/001
Wallac: Screening Center
06 November 2020
IVDs, clinical chemistry
MHRA reference: 2020/010/030/291/002
Welch Allyn: ELI 380 Resting Electrocardiograph
MOD1319
ECG
Model: ELI380-XYYZZ
X=A to Z
Y= A to Z
Z= A to Z or 1 to 9
MHRA reference: 2020/011/012/487/002