FDA Device recall Z-0049-2017
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
- 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 . Celesteion PCA-9000A/2 CT Scanner 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-0049-2017 |
| 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 . Celesteion PCA-9000A/2 CT Scanner
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 | XL 700 |
|---|
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-0049-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.