Company: Zap Surgical Systems
Date of Enforcement Report: 9/14/2022
ZAP-X Radiosurgery System
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.
Zap Surgical Systems
VOLUME OF PRODUCT IN COMMERCE
Worldwide distribution – US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.