Toshiba Kalare DREX-KL80 X-ray generator — Class II medical device recall Z-1397-2017
Terminated recall by Toshiba American Medical Systems Inc, reported 2017-03-22, distributed nationwide. It was discovered that the generator of the system could possibly terminate the exposure prematurely during an
| Recall number | Z-1397-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Toshiba American Medical Systems Inc, Tustin, CA, United States |
| Recall initiated | 2016-05-19 |
| Classified | 2017-03-14 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2018-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 254 |
| Model numbers | KXO-80XD |
Product
Toshiba Kalare DREX-KL80 X-ray generator
Reason for recall
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
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-1397-2017. 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.