Angio WorkStation — Class II medical device recall Z-2109-2017
Terminated recall by Toshiba American Medical Systems Inc, reported 2017-06-07, distributed in AL, AR, CA, CT, DE, FL, GA, ID…. It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS
| Recall number | Z-2109-2017 |
|---|---|
| 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 | 2017-02-01 |
| Classified | 2017-05-30 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2018-06-06 |
| Distributed | AL, AR, CA, CT, DE, FL, GA, ID, IL, IN, LA, MA, MD, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA |
| Quantity | 70 systems |
Product
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Reason for recall
It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
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-2109-2017. 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.