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U.S. Department of Health and Human Services

Class 2 Device Recall Toshiba Ultimax DREX ULT80 Xray generator

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  Class 2 Device Recall Toshiba Ultimax DREX ULT80 Xray generator see related information
Date Initiated by Firm May 19, 2016
Create Date March 14, 2017
Recall Status1 Terminated 3 on June 14, 2018
Recall Number Z-1398-2017
Recall Event ID 76175
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Toshiba Ultimax DREX-ULT80 X-ray generator
Code Information Model : KXO-80XM
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
FDA Determined
Cause 2		 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 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
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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