Class 2 Device Recall Toshiba Angio WorkStation (XIDFAWS801)

• Date Initiated by Firm: February 01, 2017
• Create Date: May 30, 2017
• Recall Status: Terminated on June 06, 2018
• Recall Number: Z-2109-2017
• Recall Event ID: 77195
• 510(K)Number: K152785
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
• Code Information: S/N : 8181622393
• Recalling Firm/ Manufacturer: Toshiba American Medical Systems Inc; PO Box 2068; 2441 Michelle Dr; Tustin CA 92780-7047
• For Additional Information Contact: 800-521-1968
• Manufacturer Reason for Recall: It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Toshiba Medical planned action to be taken to address the defect: CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. 3. The corrections are made free of charge to customers. 4. You complete this recall by September 30, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. For further questions, please call (800) 521-1968
• Quantity in Commerce: US - 70 systems
• Distribution: US Distribution to the states of :LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, MO, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA, WA, AR, NJ, MD, OK, IN and NH.
• 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.

• 510(K) Database: 510(K)s with Product Code = OWB