FDA Device recall Z-0047-2017
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display c…
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display c… by Toshiba American Medical Systems, citing 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 r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0047-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-25 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | 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 |
Product
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Reason
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.
Identifiers
| code_info | LL 500 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0047-2017%22
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