Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6 — Class II medical device recall Z-2188-2016
Terminated recall by Toshiba American Medical Systems Inc, reported 2016-07-27, distributed in AZ, CA, DE, FL, GA, IL, MA, MO…. During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value.
| Recall number | Z-2188-2016 |
|---|---|
| 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 | 2016-02-24 |
| Classified | 2016-07-18 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2017-04-25 |
| Distributed | AZ, CA, DE, FL, GA, IL, MA, MO, NC, NY, TX |
| Quantity | 23 |
| Reason classes | software |
| Model numbers | XIDF-AWS801 |
Product
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Reason for recall
During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
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-2188-2016. 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.