Recall Z-2109-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Toshiba American Medical Systems Inc
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
| Date | Feb 1, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root 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 packagin |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152785 | XIDF-AWS801, Angio Workstation, V6.20 Toshibamedical Systems Corporation, Nov 25, 2015 |