Field Safety Notice: 11 to 15 February 2019
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 February 2019
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
Babylon Health:Chatbot Online Doctor
13 February 2019
Diagnostic / therapeutic software algorithm
MHRA reference: 2018/005/016/291/021
Cepheid: Xpert® HBV Viral Load
08 February 2019
IVDs, Viral Microbiology
MHRA reference: 2019/002/013/701/013
Cordis: Cordis Vista Brite and ADROIT Guiding Catheter
07 February 2019
Vascular cannula and catheters
MHRA reference: 2019/002/008/487/033
Depuy Synthes: REEF™ Cementless Metaphyso-Diaphyseal Femoral Stem
February 2019
Joint prosthesis, hip
MHRA reference: 2019/002/008/487/009
GE Healthcare: CHA Anesthesia and CHA Critical Care
38000
Anaesthetic Machines & Monitors
MHRA reference: 2019/002/013/228/004
IBL International GmbH: DHEA ELISA
11 February 2019
IVDs, clinical chemistry
MHRA reference: 2019/002/012/701/011
Randox Laboratories: Blood Gas Controls Levels 1,2,3
05 February 2019
IVDs, extra laboratory testing
Model: BG5001 BG5002 BG5003
MHRA reference: 2019/002/012/601/002
Randox Laboratories:RX Modena
06 February 2019
IVDs, clinical chemistry
Model: RX9000
MHRA reference: 2019/002/012/601/006
Siemens (Advia): ADVIA Chemistry
February 2019
IVDs, clinical chemistry
MHRA reference: 2019/002/008/601/005
Siemens (Vista): Dimension Vista® Lactate Dehydrogenase (LDI)
October 2018
IVDs, clinical chemistry
Model: SMN 10464323
MHRA reference: 2019/002/008/601/004
Smith's Medical (Protect):ProtectIV Plus Safety IV Catheter
08 February 2019
Vascular cannula and catheters
MHRA reference: 2019/002/011/487/003
Smith's Medical (Portex): Portex® Blue Line Ultra® Tracheostomy Tubes
11 February 2019
Airway devices
Model: 100/856/080
MHRA reference: 2019/002/012/487/034
Stryker: LIFEPAK 15 monitor/defibrillator
06 February 2019
Defibrillators, Non-Implantable
V15-2-000XXX
MHRA reference: 2019/002/004/291/012
Swemac Innovation AB: Motec Wrist Prosthesis
22 January 2019
Joint prosthesis, misc
Model: 40-1015S Motec Wrist Prosthesis
MHRA reference: 2019/002/011/601/002
WEST Pharma. Services IL: Vial2Bag Needleless Transfer Device
28 January 2019
Infusion & transfusion, administration sets
MHRA reference: 2019/002/001/487/010
Last updated 18 February 2019 + show all updates
-
Added FSN for Stryker: LIFEPAK 15 monitor/defibrillator
-
First published.