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Zap Surgical Systems recalls ZAP-X Radiosurgery System
Recalled September 21, 2022 · FDA recall Z-1742-2022 · 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. · FDA Class II
Units
8
Sold at
Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
Description
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.
Product
ZAP-X Radiosurgery System
Manufacturer(s)
Zap Surgical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →