Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿… — Class II medical device recall Z-1175-2016
Terminated recall by Toshiba American Medical Systems Inc, reported 2016-03-30, distributed nationwide. When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating tha
| Recall number | Z-1175-2016 |
|---|---|
| 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 | 2016-01-14 |
| Classified | 2016-03-21 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2017-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 28 |
| Serial numbers | USB1522023 |
Product
Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
Reason for recall
When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the "OK" button to re-acquire the image data or to select the¿'Cancel" button to cancel the re-acquisition. As instructed the user selected "OK" and the same message window appeared. This same operation was repeated several times with the identical result - no image. Finally, the user selected "Cancel" and the re-acquisition was terminated.
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.