Recall Z-0819-05 ยท KPS System, Tomography, Computed, Emission
CTI PET Systems Inc
ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America
| Date | May 11, 2005 (initiated Apr 5, 2005) |
| Status | Terminated |
| Reason | Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit. |
| Root cause | Other |
| Action | Written notification via certified US Mail was sent out beginning 04/05/2005 to distributors and end users (with whom CTI had a service contract) to advise them of the problem. |
| Quantity | 80 units |
| Distribution | Nationwide, Canada, the Netherlands, Ireland & Denmark |
| FDA record | Open on fda.gov |