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Terminated

Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F

FDA Recall Z-2109-2017 · Posted None

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2017-02-01
Date Terminated2018-06-06
Product QuantityUS - 70 systems

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.

Firm 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

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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