Toshiba Ultimax DREX-ULT80 X-ray generator
This recall has been terminated (originally issued May 19, 2016).
- Recall Initiated
- May 19, 2016
- Terminated
- June 14, 2018
- Recall Number
- Z-1398-2017
- Quantity
- 254
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Distribution
USA ( nationwide ) Distribution to the states of : WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.
Lot / Code Info
Model : KXO-80XM
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Toshiba America Medical Systems planned action to bring defect into compliance : 1. A notification letter will be sent to customers with affected systems. This letter includes the statement that the repairs will be made at no cost to the customer. 2. Modified firmware will be installed on the systems to prevent the defect from recurring. 3. The consignees will be contacted by a Toshiba service representative for an appointment when the modified firmware becomes available 4. The consignee will be informed that if this problem occurs before the new firmware is installed; they should reset the x-ray generator to complete the exam; and 5. The CAP will be completed by May 1, 2017. For further questions please call (714) 730-5000