Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acqui
FDA device recall Z-1607-2016 · posted 2016-05-04 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Potential degradation of detector performance.
- Action taken
- Toshiba sent an Urgent Medical Device Correction letter dated April 24, 2016 to all affected customers. The letter informed customers that Toshiba America Medical Systems is bringing attention to a potential problem with the Celestion PET/CT System. The letter informed the customers of a potential degradation of detector performance and informed the customers of the problems and the corrective actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or be sent via email to regulatoryaffairs@toshiba.com. Customers with questions were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 3 units
- Distribution
- US Distribution to WI and NV.
- Date initiated
- 2016-04-24
- Date posted
- 2016-05-04
- Date terminated
- 2017-02-22
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELESTEION, PCA-9000A/2 (K140651) | Toshibamedical Systems Corporation | 2014-06-11 |