Field safety notices - 20 to 24 July 2015

List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 July 2015.


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

AngioDynamics: Morpheus Smart PICC CT

20 March 2015

Vascular Cannula and Catheters

Model: Various

MHRA reference: 2015/003/020/601/001

Argon Medical Devices: T-Lok/Bone Marrow Biopsy Needle

22 June 2015

Surgical Instruments, Minimal Access

MHRA reference: 2015/007/022/292/026

Bard: Rival® PTA Dilatation Catheter


Vascular Cannula and Catheters

MHRA reference: 2015/007/021/601/002

Mortara Dolby: ELI 380 Electrocardiograph

29 May 2015


Model: ELI380-XXXXX, ELI380-X-X

MHRA reference: 2015/006/004/701/006

Össur hf: Talux, Vari-Flex, Vari-Flex XC, Re-Flex Shock, Re‑Flex Rotate

15 July 2015


MHRA reference: 2015/007/017/291/005

Q Core: Sapphire epidural infusion pump

18 July 2015

Infusion Systems

MHRA reference: 2014/012/005/401/003

Siemens Healthcare Diagnostics: Dimension® & Dimension Vista® Creatinine

July 2015 IVDs, Clinical Chemistry

Model: Dimension - SMN 10444968 & Dimension Vista - SMN 10445161

MHRA reference: 2015/007/020/601/002

Siemens Healthcare Diagnostics Products: N Latex ß2-Microglobulin & DV Flex Reagent B2MIC

July 2015

IVDs, Clinical Chemistry Model: N Latex ß2-Microglobulin & DV Flex Reagent B2MIC (OQWU155, OQWU215; & K7024)

MHRA reference: 2015/007/017/292/001

Smith & Nephew: SURESHOT Humeral 3.2mm AO DRILL

13 July 2015

Surgical power tools

MHRA reference: 2015/007/017/291/004

Synthes: Inserter f/TEN

15 July 2015

Surgical Instruments, Implant

MHRA reference: 2015/003/003/081/012

Thermo Fisher Scientific: VERSATREK

26 June 2015

IVDs, Bacteriology

Model: Multiple

MHRA reference: 2015/007/016/601/002

Toshiba Medical Systems: Aquilion

20 July 2015

Computed Tomography

Model: Aquilion TSX-301A with system software V6.0 or later

MHRA reference: 2015/007/021/121/002

Published 24 July 2015