Medical device manufacturer, Bayer Medical Care, has issued a medical device safety alert concerning its Medrad Spectris Solaris EP MR Injection System [Catalogue number: 3012011; Serial number: 202052].
The manufacturer has determined that the battery/cable power assemblies in Spectris Solaris EP MR Injection Systems (SSEP) distributed from September – November 2016 do not meet the specifications. This could result in intermittent power failure of the device which could result in a degraded image or a delay of the imaging procedure requiring a repeat of the contrast-enhanced MR scan should it occur during a procedure. The manufacturer will replace the battery/cable power assembly for the affected users.
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 26 January 2017