Field Safety Notices: 5 to 9 September 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 September 2022
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
CareDx: QTYPE 11
01 September 2022
IVDs, Immunology
MHRA reference: 2022/009/005/599/010
GE Healthcare: Aisys CS2, Avance CS2, Avance CS2 Pro
Ref 34129
Anaesthetic Machines & Monitors
MHRA reference: 2022/009/005/599/011
Getinge: 701069073, 701069076, 701069083 HLS Set Advanced 5.0, HLS Set Advanced 7.0
12 August 2022
Infusion & Transfusion, Heart Lung Circuits
MHRA reference: 2022/007/026/596/004
This is an update to the FSN first published in July 2022. The same products and lots are affected, which were already reported in the previous version of the FSN 656504. No additional or new actions for customers were added.
Getinge: Heater Unit HU 35
Ref 598097
Blood/Fluid Warming Systems
Model: 70103.5259; 70104.9090; 70107.2162; 70107.2163
MHRA reference: 2022/009/005/596/001
Integra: Codman CereLink ICP Monitor
30 August 2022
Monitors, Patient
Model: 826820
MHRA reference: 2022/006/028/613/008
Philips: BiPAP A30 Ventilator (Respironics, Inc.) BiPAP A40
08 September 2022
Lung Ventilators
MHRA reference: 2022/008/005/596/008
This FSN only affects 40 devices. Please check if you have a device with a serial number which appears on the list within the FSN and follow the actions to be taken. No action is needed if your device serial number is not on the list.
Siemens: N Antiserum to Human IgG
August 2022
IVDs, Clinical Chemistry
MHRA reference: 2022/009/005/596/002