Field Safety Notices: 10 to 14 May 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 10 to 14 May 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
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View . FSNs before this date are on the
BD: T34 Ambulatory Syringe Pump 3rd Edition
10 May 2021
Infusion systems
MHRA reference:
Becton Dickinson: Group B Streptococcus Differential Agar (Granada)
10 May 2021
IVDs, bacteriology
MHRA reference:
Bosch Healthcare: SARS-CoV-2 and SARS-CoV-2 Pooling
10 May 2021
IVDs, SARS-CoV-2 PCR test
MHRA reference:
GE Medical Systems: Innova IGS system
7 May 2021
X Ray, fluoroscopy systems
MHRA reference:
Getinge: VHK and VKMO Neonatal
10 May 2021
Infusion & transfusion, heart lung circuits
Model: 701048596, 701051430, 701054173, 701050109, 701053443, 701049279, 701053444, 701063847, 701070440, 701070444, 701071077
MHRA reference:
Getinge MX-8224: SoKINOX, SERViNO
10 May 2021
Lung ventilators
MHRA reference:
Implants International: ROTOglide MTP System
23 March 2021
Joint prosthesis, toe
Model: Various
MHRA reference:
NeuMoDx Molecular, a QIAGEN company: NeuMoDx Cartridge
10 May 2021
IVDs, clinical chemistry
MHRA reference:
NHS Digital: Covid-19 Risk Assessment Service
7 April 2021
Software as a medical device (SaMD)
Model: Release 1
MHRA reference:
OptiMed: Cemento Mini Set for Cemento-MP
6 April 2021
Bone cement and tools
Model: 1382-0100
MHRA reference:
Smiths Medical: Jelco Hypodermic Insulin Needles
17 May 2021
Insulin injection devices
Model: 4428-1, 4429-1
MHRA reference:
Synaptive Medical: Synaptive Trackable Suction
30 April 2021
Surgical equipment
MHRA reference:
SynCardia Systems: Companion 2 Driver System
6 May 2021
Implantable ventricular assist devices
MHRA reference:
Trinity Biotech: Captia NMT Syphilis IgM
5 May 2021
IVDs, bacteriology
MHRA reference:
Zimmer: Natural Nail Cephalomedullary Nail
7 May 2021
Osteosynthesis, bone screws
Model: 47-2493-211-11; 47-2493-213-11
MHRA reference: