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
Babylon Health:Chatbot Online Doctor
13 February 2019
Diagnostic / therapeutic software algorithm
MHRA reference:
Cepheid: Xpert庐 HBV Viral Load
08 February 2019
IVDs, Viral Microbiology
MHRA reference:
Cordis: Cordis Vista Brite and ADROIT Guiding Catheter
07 February 2019
Vascular cannula and catheters
MHRA reference:
Depuy Synthes: REEF鈩� Cementless Metaphyso-Diaphyseal Femoral Stem
February 2019
Joint prosthesis, hip
MHRA reference:
GE Healthcare: CHA Anesthesia and CHA Critical Care
38000
Anaesthetic Machines & Monitors
MHRA reference:
IBL International GmbH: DHEA ELISA
11 February 2019
IVDs, clinical chemistry
MHRA reference:
Randox Laboratories: Blood Gas Controls Levels 1,2,3
05 February 2019
IVDs, extra laboratory testing
Model: BG5001 BG5002 BG5003
MHRA reference:
Randox Laboratories:RX Modena
06 February 2019
IVDs, clinical chemistry
Model: RX9000
MHRA reference:
Siemens (Advia): ADVIA Chemistry
February 2019
IVDs, clinical chemistry
MHRA reference:
Siemens (Vista): Dimension Vista庐 Lactate Dehydrogenase (LDI)
October 2018
IVDs, clinical chemistry
Model: SMN 10464323
MHRA reference:
Smith's Medical (Protect):ProtectIV Plus Safety IV Catheter
08 February 2019
Vascular cannula and catheters
MHRA reference:
Smith's Medical (Portex): Portex庐 Blue Line Ultra庐 Tracheostomy Tubes
11 February 2019
Airway devices
Model: 100/856/080
MHRA reference:
Stryker: LIFEPAK 15 monitor/defibrillator
06 February 2019
Defibrillators, Non-Implantable
V15-2-000XXX
MHRA reference:
Swemac Innovation AB: Motec Wrist Prosthesis
22 January 2019
Joint prosthesis, misc
Model: 40-1015S Motec Wrist Prosthesis
MHRA reference:
WEST Pharma. Services IL: Vial2Bag Needleless Transfer Device
28 January 2019
Infusion & transfusion, administration sets
MHRA reference:
Updates to this page
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Added FSN for Stryker: LIFEPAK 15 monitor/defibrillator
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First published.