Field Safety Notices: 21 to 24 December 2020
List of field safety notices (FSNs) from medical device manufacturers from 21 December to 24 December 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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Argon Medical: TLAB Transjugular Liver Biopsy System
10 December 2020
Surgical instruments, minimal access
Model: TL-18C, TL-18N, TL-18S, TL-19, TL-19N, and TL-19S
MHRA reference:
Baxter Healthcare: One-Link Non-DEHP Y-Type Microbore Catheter Extens
21 December 2020
Infusion & transfusion, administration sets
MHRA reference:
Biomet(Zimmer): Multiple Sterile Zimmer Biomet Products
17 December 2020
Various devices affected
MHRA reference:
Bioventus: EXOGEN Ultrasound Gel
14 December 2020
Ultrasound, therapy
Model: See comments section 8
MHRA reference:
CareDx Pty: AlloSeq Assign
14 December 2020
IVDs, bacteriology
MHRA reference:
Enbiotech: ICGENE Plus
17 December 2020
IVDs, SARS-CoV-2 PCR test
MHRA reference:
Getinge: CM320
21 December 2020
Cssd wash/clean/drying equipment
MHRA reference:
Maquet(Getinge): Pediatric Venous Hardshell Cardiotomy Reservoir
16 December 2020
Infusion & transfusion, heart lung circuits
Model: 01050111, 701053454, 701049185, 701053455, 701048595, 701051432, 701054166, 701070422
MHRA reference:
Medartis: MODUS and MODUS 2 Pliers
17 December 2020
Orthopaedic surgical instruments - insertion/extraction tools
Model: 2.0-2.5 Three-Point Bending Pliers, 2.0-2.5 Plate Bending Pliers, 2.5 Plate Bending Plier
MHRA reference:
Medtronic FA 949: Intellis Clinician Programmer Application
December 2020
Implantable neuro stimulators
Model: A710
MHRA reference:
Medtronic: HVAD� Pump
December 2020
Implantable ventricular assist devices
Model: 1104
MHRA reference:
Ortho-Clinical: ORTHO VISION and VISION Max Analyzers
December 2020
IVDs, blood transfusion
Model: 6904579 and 6904578
MHRA reference:
Philips: Philips-EPIQ Ultrasound system
FSCA 79500545A-IR
Software as a medical device (SaMD)
Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi)
MHRA reference:
Roche Diagnostics: 9180 Electrolyte Analyzer
December 2020
IVDs, clinical chemistry
Model: 03157334001
MHRA reference:
Zimmer Surgical: Spinal Rod Cutter
17 December 2020
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: