FDA-Device2022-09-21Class II
ZAP-X Radiosurgery System
Zap Surgical Systems
Hazard
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.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
Affected count
8
Manufactured in
590 Taylor Way, San Carlos, CA, United States
Products
ZAP-X Radiosurgery System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1742-2022Don't want to check this manually?
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