FDA Device recall Z-0005-2016
Celesteion PCA-9000A/2 PET/CT System
- FDA Device
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of Celesteion PCA-9000A/2 PET/CT System by Toshiba American Medical Systems, citing it was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0005-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-08 |
| Published | 2015-10-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | NV |
Product
Celesteion PCA-9000A/2 PET/CT System
Reason
It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.
Identifiers
| code_info | Model: TSX-301 CI6A with system software V7.0 SPOO04J |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0005-2016%22
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