FDA Device recall Z-2282-2012
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system
- FDA Device
- Class II
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class II recall of Whole Body X--ray Scanner This device is indicated as a whole body volume CT system by Toshiba American Medical Systems, citing 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) ar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2282-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2009-07-13 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
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
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
Identifiers
| code_info | Serial Number: 2DA0882051 |
|---|
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-2282-2012%22
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