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:
Argon Medical Devices: T-Lok/Bone Marrow Biopsy Needle
22 June 2015
Surgical Instruments, Minimal Access
MHRA reference:
Bard: Rival庐 PTA Dilatation Catheter
FA2015-25
Vascular Cannula and Catheters
MHRA reference:
Mortara Dolby: ELI 380 Electrocardiograph
29 May 2015
ECG
Model: ELI380-XXXXX, ELI380-X-X
MHRA reference:
脰ssur hf: Talux, Vari-Flex, Vari-Flex XC, Re-Flex Shock, Re鈥慒lex Rotate
15 July 2015
Prostheses
MHRA reference:
Q Core: Sapphire epidural infusion pump
18 July 2015
Infusion Systems
MHRA reference:
Siemens Healthcare Diagnostics: Dimension庐 & Dimension Vista庐 Creatinine
July 2015 IVDs, Clinical Chemistry
Model: Dimension - SMN 10444968 & Dimension Vista - SMN 10445161
MHRA reference:
Siemens Healthcare Diagnostics Products: N Latex 脽2-Microglobulin & DV Flex Reagent B2MIC
July 2015
IVDs, Clinical Chemistry Model: N Latex 脽2-Microglobulin & DV Flex Reagent B2MIC (OQWU155, OQWU215; & K7024)
MHRA reference:
Smith & Nephew: SURESHOT Humeral 3.2mm AO DRILL
13 July 2015
Surgical power tools
MHRA reference:
Synthes: Inserter f/TEN
15 July 2015
Surgical Instruments, Implant
MHRA reference:
Thermo Fisher Scientific: VERSATREK
26 June 2015
IVDs, Bacteriology
Model: Multiple
MHRA reference:
Toshiba Medical Systems: Aquilion
20 July 2015
Computed Tomography
Model: Aquilion TSX-301A with system software V6.0 or later
MHRA reference: