Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning its Expression MR400 MRI Patient Monitoring System (866185) [Software Revision: 01.03.00, 01.04.00, 01.05.00 and 01.07.00].
According to the manufacturer, for MR400 devices with software revisions 01.03.00, 01.04.00, 01.05.00 and 01.07.00, the menu selections for users to access the O2 sensor calibration were changed. These changes were not incorporated into the device's Instructions for Use. As a result, the instructions for performing the O2 sensor calibration are incorrect for users performing this task with an MR400 device with these software revisions.
The manufacturer has included an Instructions for Use addendum (Part Number 453564720941; Revision B) with the Customer Information Letter which provides correct instructions for accessing the O2 sensor calibration menu, as well as other updated product information. Affected users should ensure that the information contained in the addendum is communicated to all users and servicers and is retained with the MR400 Instructions for Use. The manufacturer has no further actions beyond providing the Instructions for Use Addendum.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 March 2020