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