Field safety notices - 20 to 24 July 2015
List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 July 2015.
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
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
FA2015-25
Vascular Cannula and Catheters
MHRA reference: 2015/007/021/601/002
Mortara Dolby: ELI 380 Electrocardiograph
29 May 2015
ECG
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
Prostheses
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