Field safety notices - 2 to 6 July 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 July 2018.
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
CSC (DXC Technology): iLAB AKI 2.1 Build 5
26 June 2018
IVDs, clinical chemistry
MHRA reference: 2017/002/014/701/015
Cepheid: Xpert MTB/RIF Ultra
14 June 2018
IVDs, bacteriology
MHRA reference: 2018/006/029/701/010
Fresenius: 5008 CorDiax HD-PAED option
26 June 2018
Dialysis, haemodialysis
MHRA reference: 2018/007/005/291/001
GE Medical Systems: refer to the field "Accessories/associated device"
60936
Magnetic resonance, equipment & accessories
MHRA reference: 2018/006/028/081/004
Intuitive Surgical: da Vinci® Si™ / Xi™ / X™ Surgical System
ISIFA2018-05-C
Endoscopes, rigid
Model: IS3000 / IS4000 / IS4200 Surgeon Side Console; IS3000 Patient Side Cart
MHRA reference: 2018/006/028/701/018
Medtronic: Guardian™ Connect Application
July 2018
Continuous glucose monitoring systems (CGMS)
Model: CSS7200
MHRA reference: 2018/007/005/291/044
Medtronic: Visualase™ Thermal Therapy System
June 2018
Magnetic resonance, equipment & accessories
Model: 9735542
MHRA reference: 2018/007/003/291/040
RaySearch Laboratories: RayStation
29 June 2018
IVDs, clinical chemistry
Model: RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A
MHRA reference: 2018/007/002/701/021
Roche
25 June 2018
Cobas p612 pre-analytical system (LCP1)
Model: 07563116001
MHRA reference: 2018/006/029/701/006
Siemens: Atellica IM 1300 Analyzer /Atellica IM 1600 Analyzer /Atellica CH 930 Analyzer /Atellica Sample Handler Prime / Atellica Sample Handler Connect / Atellica Sample Handler Additional
June 2018
IVDs, clinical chemistry
MHRA reference: 2018/007/003/601/008
Thermo Fisher Scientific: Thermo Scientific EZ Single Cytofunnel
04 January 2018
IVDs, cytopathology & histopathology
Model: A78710004
MHRA reference: 2018/007/002/601/002
Thermo Fisher Scientific: Gibco™ RPMI 1640 Medium
19 June 2018
IVDs, bacteriology
MHRA reference: 2018/007/004/291/001
WEINMANN Emergency Medical: WM 28300 und WM 28400
02 July 2018
Lung ventilators
MHRA reference: 2018/007/003/291/032