Recall Z-1397-2017 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Toshiba American Medical Systems Inc
Toshiba Kalare DREX-KL80 X-ray generator
| Date | May 19, 2016 |
| Status | Terminated |
| Reason | It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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 |
| Quantity | 254 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.