Toshiba America Medical Systems — Class II medical device recall Z-0048-2017
Terminated recall by Toshiba American Medical Systems Inc, reported 2016-10-12, distributed in AL, AR, CA, CO, CT, FL, GA, HI…. It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction oper
| Recall number | Z-0048-2017 |
|---|---|
| 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 | 2016-04-25 |
| Classified | 2016-10-06 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-07-13 |
| Distributed | AL, AR, CA, CO, CT, FL, GA, HI, IA, ID, IN, KS, KY, LA, MA, MI, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, PA, SC, SD, TN, VT, WA, WI, WV |
| Quantity | 165 |
Product
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Reason for recall
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
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-0048-2017. 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.