Events

Safety Alert for sat 805 and sat 816 pulse oximeters

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

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
    2012-12-11
  • Event Date Posted
    2012-12-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121211a.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: bitmos sat 805 and sat 816 pulse oximeters the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning sat 805 and sat 816 pulse oximeters manufactured by bitmos. according to the manufacturer, the affected products may stop monitoring, providing dashes on the display and not providing an audible or visual notification to identify the change in state. the manufacturer advises the affected users to suspend the use of the products immediately and return the affected products for software update. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con213146 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 december 2012.

Device

sat 805 and sat 816 pulse oximeters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bitmos sat 805 and sat 816 pulse oximeters
  • Manufacturer
    Bitmos

Manufacturer

Bitmos