Events

Safety Alert for PROCARE B20 and B40 Monitors

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by GE Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-11-06
  • Event Date Posted
    2012-11-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121106.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ge procare b20 and b40 monitors 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.

Device

PROCARE B20 and B40 Monitors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE PROCARE B20 and B40 Monitors
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare