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 7/601/006

Published 18 September 2017