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
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Abbott: Alinity c Processing Module
12 May 2020
IVDs, clinical chemistry
MHRA reference:
Draeger: various (all heated breathing circuits)
May 2020
Humidifiers
Model: various
MHRA reference:
Fast Track Diagnostics: FTD Stool parasites
April 2020
IVDs, viral microbiology
Model: Siemens Material Number 10921736 / 10921737
MHRA reference:
Natus: Bedside to Patient Unit Cable (PURU3)
May 2020
Beds and accessories
MHRA reference:
Ortho-Clinical: VITROS庐 3600 Immunodiagnostic System (includes Refurbished systems), VITROS庐 5600 Integrated System (includes Refurbished systems), VITROS庐 XT 7600 Integrated System
CL2020-126
IVDs, clinical chemistry
MHRA reference:
Siemens: IMMULITE 2000 / 2000 XPi Immunoassay systems
May 2020
IVDs, clinical chemistry
MHRA reference:
Smiths Medical: 3.0MM Hyperflex Tracheostomy Uncuffed, Adjust, Nec
18 May
Airway devices
Model: 60HA30
MHRA reference:
Stereotaxis: Niobe ES
04 May 2020
Therapy tissue ablation
Model: 3.2
MHRA reference:
Zimmer Biomet: TiMAX 6.5mm/8.0mm Large Cannulated Screw System
20 May 2020
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: