Field Safety Notices: 18 to 22 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 October 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.
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FSNs before this date are on the
Acumed: Acu-Loc庐 2 VDR Plt Std R 70-0357
07 October 2021
Osteosynthesis, bone plates
MHRA reference:
BioM茅rieux: BioFire BCID2 Panel
20 October 2021
IVDs, bacteriology
MHRA reference:
BioM茅rieux: VIDAS庐 Immuno-Assays
04 November 2021
IVDs, viral microbiology
MHRA reference:
Copan Italia: Eswab
October 2021
IVDs, specimen receptacles
MHRA reference:
Emergo Consulting (Balt): IVA
13 October 2021
Vascular cannula and catheters
Model: VA3F50, IVA5F45, IVA5F41.45, IVA5F96.45, IVA6F80, EIVA6F80, IVA6F80ST, EIVA6F80ST, IVA6F80ST_MP, EIVA6F80ST_MP, IVA7F41.45, IVA7F96.45 and IVA7F96.90
MHRA reference:
Gas Control Equipment: COMBILITE庐 SERIES
16 September 2021
Regulators for gas cylinders
Model: Pure Oxygen Version
MHRA reference:
Hamilton Medical: HAMILTON-C3
05 October 2021
Lung ventilators
Model: 160005
MHRA reference:
Integra Lifescience: Accudrain / Hermetic / LimiTorr / MoniTorr
29 September 2021
Cerebrospinal fluid drainage, external
MHRA reference:
Integrum: Axor II
06 October 2021
Prostheses
Model: 1288
MHRA reference:
Joerns Healthcare: Oxford / HOYER
15 October 2021
Moving & handling
Model: OXF-UP / HOY-UP
MHRA reference:
Medtronic: Percept PC BrainSense
October 2021
Implantable neuro stimulators
Model: B35200
MHRA reference:
Medtronic FA1191: CareLink SmartSync Device Manager
October 2021
Implants, active, cardiac programmers and remote monitoring
Model: 24970A; 24967
MHRA reference:
Permobil: TiLite AERO Z
CAPA10090 AERO Zs
Wheelchairs, manual
MHRA reference:
Permobil: TiLite ZRA
CAPA10090 ZRAs
Wheelchairs, manual
MHRA reference:
Philips: Azurion R2.1.x
October 2021
X Ray, fluoroscopy systems
Model: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228
MHRA reference:
Siemens Healthcare: Artis zee / Q / Q.zen
October 2021
X Ray, fluoroscopy systems
MHRA reference:
Siemens Healthcare Diagnostics: Aptio Automation & FlexLab Automation
September 2021
IVDs, clinical chemistry
MHRA reference:
Siemens Healthcare Diagnostics LASW 21-01: Aptio Automation
October 2021
IVDs, clinical chemistry
Model: SMN 10703038
MHRA reference:
Thermo Fisher: Pathodxtra Strep Group D Late
05 October 2021
IVDs, bacteriology
Model: DR0704G
MHRA reference:
Thermo Fisher Scientific: OxoidTM Egg Yolk Tellurite Emulsion
15 October 2021
IVDs, bacteriology
Model: SR0054C
MHRA reference: