Toshiba American Medical Systems Celesteion — Class II medical device recall Z-1607-2016
Terminated recall by Toshiba American Medical Systems Inc, reported 2016-05-11, distributed in NV, WI. Potential degradation of detector performance.
| Recall number | Z-1607-2016 |
|---|---|
| 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 | 2016-04-24 |
| Classified | 2016-05-04 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-02-22 |
| Distributed | NV, WI |
| Quantity | 3 units |
| Reason classes | specification failure |
| Serial numbers | 2881492002, 3BA1562001, 3BA1572002 |
| Model numbers | 9000A/2B, 9000A/3B, PCA-9000A/2 |
Product
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.
Reason for recall
Potential degradation of detector performance.
Machine access
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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.