Company: Zap Surgical Systems
Date of Enforcement Report: 9/14/2022
Class II
PRODUCT
ZAP-X Radiosurgery System
Recall Number:
Z-1742-2022
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.
RECALLING FIRM/MANUFACTURER
Zap Surgical Systems
VOLUME OF PRODUCT IN COMMERCE
8
DISTRIBUTION
Worldwide distribution – US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
