BEUDAMED
    FDA Enforcement Class II Ongoing

    ZAP-X Radiosurgery System

    Recall: Z-1742-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1742-2022
    Event ID
    90716
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zap Surgical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2022
    Initiation Date
    July 5, 2022
    Classification Date
    September 14, 2022
    Address
    590 Taylor Way, San Carlos, CA, 94070-6307, United States

    Description

    ZAP-X Radiosurgery System

    Reason

    Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter.

    Code Info

    UDI-DI: 00860183001504, Serial Numbers, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.

    Quantity

    8