FDA Device recall Z-1397-2017
Toshiba Kalare DREX-KL80 X-ray generator
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of Toshiba Kalare DREX-KL80 X-ray generator by Toshiba American Medical Systems, citing it was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1397-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-19 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
Product
Toshiba Kalare DREX-KL80 X-ray generator
Reason
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Identifiers
| code_info | Model : KXO-80XD |
|---|
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-1397-2017%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.