Emission Computed Tomography System
FDA device recall Z-1079-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Adac Labs
- Reason for recall
- Software problems may cause the detector head to drift unexpectedly
- Action taken
- Notification letter sent to consignees 6/21/2004, software update pending (mandatory upgrade)
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 482 units
- Distribution
- Nationwide, all direct accounts
- Date initiated
- 2004-06-21
- Date posted
- 2004-07-20
- Date terminated
- 2005-12-19
- Location
- Milpitas, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOCAM MODEL 9CSY0799 (K011611) | Danish Diagnostic Development A/S | 2001-06-08 |