Medical DeviceView official recall notice →
Spectral CT 7500 on Rails; Product Code (REF): 728334;
Brand / Firm
Product
Spectral CT 7500 on Rails; Product Code (REF): 728334;
Reason for recall
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Units affected
3 units
Description
Spectral CT 7500 on Rails; Product Code (REF): 728334;