Field Safety Notices - 10 to 14 February 2020
Summary List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 February 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
View the latest FSNs
Acumed: 7.0mm x 2.0mm Stem (ARH System or ARH Solutions)
04 February 2020 Joint prosthesis, elbow Model: TR-S702-S MHRA reference: 2020/002/011/291/002
CardinalHealth (Medtronic): Force TriVerse™ Electrosurgical Device Holster 10’, Force TriVerse™ Electrosurgical Device Holster 15’
February 2020 Surgical, diathermy MHRA reference: 2020/002/011/291/001
Limacorporate: H-MAX S stem; DELTA Liner, MINIMA S Stem, DELTA Multihole TT Cup, Protruded DELTA LIne
07 February 2020 Joint prosthesis, hip MHRA reference: 2020/002/010/291/001
Nextremity: Nextra Hammertoe Correction System
12 February 2020 Osteosynthesis, bone screws Model: NX-4532K MHRA reference: 2020/002/012/701/054
Omixon Biocomputing: Holotype HLA 24/11 - Configuration A2 & CE v2, Holotype HLA 24/11 - Configuration A1 & CE v2, Holotype HLA 24/7 - Configuration A1 & CE v2, Holotype HLA 24/7 - Configuration A2 & CE v2
10 February 2020 IVDs, immunology MHRA reference: 2020/002/007/291/006
Randox Laboratories: LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1
12 February 2020
IVDs, clinical chemistry Model: LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1 LAL4213 MHRA reference: 2020/002/012/601/003
Schiller Medical: DEFIGARD Touch 7
December 2019 Defibrillators, non-implantable MHRA reference: 2020/002/007/291/001
Siemens Healthcare: Ysio
January 2020 X Ray, general Model: 10281013 MHRA reference: 2020/002/007/601/005
TORNIER: Impactor MoPyC
07 February 2020 Orthopaedic surgical instruments - impacting tools MHRA reference: 2020/002/003/291/004
Vygon: octopus
12 February 2020 Infusion & transfusion, administration sets Model: 842.312 MHRA reference: 2020/002/013/291/012
Wassenburg Medical B.V: WASSENBURG DRY320 drying cabinet
03 February 2020 Cssd wash/clean/drying equipment MHRA reference: 2020/001/030/601/001