The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning PROCARE B20 and B40 Monitors, manufactured by GE Healthcare.
According to the manufacturer, the 'V Tachy' and 'V Fib' alarms of Monitor PROCARE B20 or PROCARE B40 are disabled in NEONATAL mode which could result in a missed lethal arrhythmia alarm and a potentially critical event. Other modes and parameters are not affected. The issue affects Monitor PROCARE B20 or B40 devices with the software version VSP-A_1.10 (or earlier).
The manufacturer advised clinician should stop using monitor in NEONATAL mode. they will provide a software solution to correct this issue.
For details, please refer to MHRA website http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON199544
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 6 November 2012