Recall Z-1398-2017— Toshiba American Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2016-05-19, terminated 2018-06-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Toshiba Ultimax DREX-ULT80 X-ray generator. Reason: It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination.
- Recalling firm
- Toshiba American Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-19
- Terminated
- 2018-06-14
- Firm location
- Tustin, CA, United States
Product description
Toshiba Ultimax DREX-ULT80 X-ray generator
Reason for recall
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Data sourced from openFDA. This site is unofficial and independent of the FDA.