TOSHIBA Kalare Diagnostic X-Ray System K110785 — Class II medical device recall Z-1598-2013
Terminated recall by Toshiba American Medical Systems Inc, reported 2013-07-17, distributed nationwide. Firm initiated recall because when radiographic conditions with the small focus are set and the radiography re
| Recall number | Z-1598-2013 |
|---|---|
| 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 | 2013-04-03 |
| Classified | 2013-07-10 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2016-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 153 units |
Product
TOSHIBA Kalare Diagnostic X-Ray System K110785
Reason for recall
Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.
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-1598-2013. 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.