Field Safety Notice - 11 to 15 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 September 2017.
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
BIOMERIEUX
22 August 2017
IVDs, bacteriology
Model: VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit
MHRA reference: 2017/009/013/291/036
Biomet
11 September 2017
Joint prosthesis, elbow
Model: ExploR 6x24mm implantable stem with screw
MHRA reference: 2017/009/012/701/014
Biomet: Ziptight Ankle Syndesmosis Fixation
31 August 2017
Ligaments, tendons and anchors
Model: N/A
MHRA reference: 2017/009/008/701/006
Biosense Webster
6 September 2017
Therapy tissue ablation
Model: THERMOCOOL® SF NAV and THERMOCOOL SMARTTOUCH® SF
MHRA reference: 2017/009/013/701/005
CRISTALENS INDUSTRIE: ARTIS, EAZ, LUXIOL, NAVIGO
05 September 2017
Implants, non-active, intraocular
MHRA reference: 2017/009/008/701/005
Convatec: See FSN
31 August 2017
Anaesthetic & breathing, masks
Model: See FSN
MHRA reference: 2017/005/009/701/010
Medtronic MiniMed Infusion Sets
September 2017
Infusion & Transfusion, Administration Sets
Models:
Medtronic MiniMed Quick-set (MMT-394, 384, 399, 387, 398, 397, 386, 396)
Medtronic MiniMed Silhouette (MMT-377, 378, 384, 368, 381, 382, 383)
Medtronic MiniMed Sure-T (MMT-862, 862T, 864, 866, 874, 876, 884, 886)
Medtronic MiniMed Mio (MMT-921, 923, 925, 941, 943, 945, 961, 963, 965, 975)
Medtronic MiniMed Mio 30 (MMT-905, 906)
MHRA reference: 2017/009/013/291/003
Depuy Synthes: DELTA XTEND™ Reverse Shoulder System
September 2017
Joint prosthesis, shoulder
Model: 130720101,130720102,130720103,130720201,130720202,130720203
MHRA reference: 2017/009/013/701/007
Oculentis BV: LENTIS
12 September 2017
Implants, non-active, intraocular
Model: LENTIS - All models starting with L or LS or LU
MHRA reference: 2017/009/013/291/009
Philips: X-ray system, diagnostic, computed tomography, full-body
08 September 2017
Computed tomography
Model: Brilliance iCT SP (728311), Brilliance iCT (728306)
MHRA reference: 2017/009/015/291/001
Randox Laboratories: Liquid Cardiac Control - Level 3
1 August 2017
IVDs, clinical chemistry
Model: CQ5053
MHRA reference: 2017/008/003/601/004
Sebia: MINICAP PROTEIN(E) 6
24 August 2017
IVDs, clinical chemistry
Model: 2203
MHRA reference: 2017/009/013/291/012
Siemens
04 September 2017
X Ray, fluoroscopy systems
Model: Artis zee/Artis Q
MHRA reference: 2017/009/008/601/005
Siemens: Enzygnost HBsAg 6.0
September 2017
IVDs, viral microbiology
Model: SMN 10446017 & 10446016
MHRA reference: 2017/009/014/291/020
Siemens: ACUSON S Family with SW vers. VD10A or VD10C
US004/17/S
Ultrasound, Imaging
Model: 10441701, 10041461, 10440017
MHRA reference: 2017/006/029/601/012
Thermofisher Scientific: Thermo Scientific Oxoid Antimicrobial Susceptibility Test disc CAZ10 Ceftazidime
5 September 2017
IVDs, bacteriology
Model: Thermo Scientific Oxoid Antimicrobial Susceptibility Test disc CAZ10 Ceftazidime CT1629B
MHRA reference: 2017/009/00