Field Safety Notices: 21 to 25 January 2019
List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 January 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
BIOMERIEUX
17 January 2019
IVDs, bacteriology
MHRA reference:
CME McKinley: T34 Syringe Driver
January 2019
Infusion systems
MHRA reference:
Cook Medical: Brand
08 January 2019
Urinary catheters and accessories
guidewire
MHRA reference:
Dako: Dako Slide Racks
17 January 2019
IVDs, cytopathology & histopathology
MHRA reference:
GE: Centricity Universal Viewer
GEHC Ref# 85448
Picture Archiving and Communication System (PACS)
MHRA reference:
Medtronic: Adapta鈩�, Versa鈩�, Sensia鈩�, Relia鈩�, Attesta鈩�, Sphera鈩�, and Vitatron鈩� A, E, G, Q series Implantable Pulse Generators (IPG)
January 2019
Implants, active, pacemakers
Distributed between 10 March 2017 and 7 January 2019
MHRA reference:
Medtronic: CareLink Programmer & CareLink Encore Programmer
January 2019
Implants, active, cardiac programmers and remote monitoring
MHRA reference:
Natus: neoBLUE blanket Phototherapy LED System
December 2018
Therapy, infant phototherapy
MHRA reference:
Philips: Philips Efficia Monitors (CM10/12/100/120/150)
18 December 2018
Monitors, patient
The affected products are all Efficia CM Monitors manufactured before Oct 25, 2018 that are capable of operating under battery power and have lithium-ion batteries presently installed
MHRA reference:
Terumo: HydroPearl庐 microspheres
18 January 2019
Implants, non-active, embolisation products
8HP2S600
MHRA reference:
Thermo Fisher: Oxoid
22 January 2019
IVDs, bacteriology
Model: PB1229A
MHRA reference: