Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
This recall has been terminated (originally issued February 1, 2017).
- Recall Initiated
- February 1, 2017
- Terminated
- June 6, 2018
- Recall Number
- Z-2109-2017
- Quantity
- US - 70 systems
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
S/N : 8181622393
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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