Class 2 Device Recall Toshiba Kalare DREX KL80 Xray generator

• Date Initiated by Firm: May 19, 2016
• Create Date: March 14, 2017
• Recall Status: Terminated on June 14, 2018
• Recall Number: Z-1397-2017
• Recall Event ID: 76175
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: Toshiba Kalare DREX-KL80 X-ray generator
• Code Information: Model : KXO-80XD
• FEI Number: 2020563
• 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: 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.