Whole Body X--ray Scanner This device is indicated as a whole body… — Class II medical device recall Z-2282-2012
Terminated recall by Toshiba American Medical Systems Inc, reported 2012-09-05, distributed nationwide. 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in
| Recall number | Z-2282-2012 |
|---|---|
| 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 | 2009-07-13 |
| Classified | 2012-08-28 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2012-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 24 systems |
| Serial numbers | 2DA0882051 |
Product
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Reason for recall
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco
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.