Recall Z-1079-04 ยท KPS System, Tomography, Computed, Emission
Adac Labs
Emission Computed Tomography System
| Date | Jul 20, 2004 (initiated Jun 21, 2004) |
| Status | Terminated |
| Reason | Software problems may cause the detector head to drift unexpectedly |
| Root cause | Other |
| Action | Notification letter sent to consignees 6/21/2004, software update pending (mandatory upgrade) |
| Quantity | 482 units |
| Distribution | Nationwide, all direct accounts |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011611 | CARDIOCAM MODEL 9CSY0799 Danish Diagnostic Development A/S, Jun 8, 2001 |