The Medicines and Healthcare products Regulatory Agencies (MHRA), United Kingdom has issued a field safety notice on Ambulatory Blood Pressure Monitor, Model 90217A, manufactured by Spacelabs Healthcare.
The manufacturer has identified a potential error code associated with the use of the product. If external pressure is applied to the cuff during deflation, the monitor will cease to function and display an EC75 error code. According to the manufacturer, there have been no injuries associated with this issue.
Spacelabs Healthcare suggests the users to cycle the power off if error code is observed. The manufacturer is in the progress of upgrading the software.
For details, please refer to the following MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.