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Terminated

Toshiba Ultimax DREX-ULT80 X-ray generator

FDA Recall Z-1398-2017 · Posted None

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2016-05-19
Date Terminated2018-06-14
Product Quantity254

Reason for Recall

It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination

Firm 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 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

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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