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
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ALCIS: ALBAFLEX dental arch
2 November 2020
Dental appliances / instruments
Model: 2099-AN
MHRA reference:
Becton Dickinson: Alaris鈩� GP and GP Guardrails, Alaris鈩� neXus GP
10 November 2020
Infusion systems
MHRA reference:
Cardinal Health: Protexis Latex Micro Surgical Gloves
October 2020
Gloves, surgical & examination
MHRA reference:
GE Healthcare: 2030360-001
GEHC Ref# 30097
ECG
MHRA reference:
Kunshan Aoshida Electric Technology: Freedom Chair
2 September 2020
Wheelchairs, powered
Model: A06L
MHRA reference:
Microbiologics: KWIK-STIK鈩� 2or6 Pack 01145 /QC Sets & Panels 5226P
05 October 2020
IVDs, bacteriology
Model: Catalog 01145P Klebsiella pneumoniae derived from NCTC
MHRA reference:
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:
SD Biosensor: Total 7 products including SARS-CoV-2 Rapid Antigen Test
09 November 2020
IVDs, SARS-CoV-2 PCR Test
MHRA reference:
Stereotaxis: Niobe ES
28 October 2020
Surgical navigation system and accessories
Model: 3.2
MHRA reference:
Stryker: Mako Integrated Cutting System (MICS)
5 November 2020
Surgical power tools
MHRA reference:
Wallac: Screening Center
06 November 2020
IVDs, clinical chemistry
MHRA reference:
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: