Celesteion PCA-9000A/2 PET/CT System — Class II medical device recall Z-0005-2016
Terminated recall by Toshiba American Medical Systems Inc, reported 2015-10-14, distributed in NV. It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data
| Recall number | Z-0005-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Toshiba American Medical Systems Inc, Tustin, CA, United States |
| Recall initiated | 2015-05-08 |
| Classified | 2015-10-07 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2015-12-03 |
| Distributed | NV |
| Quantity | 1 |
| Reason classes | software |
| Model numbers | CI6A, TSX-301 |
Product
Celesteion PCA-9000A/2 PET/CT System
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0005-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.