ZAP-X Radiosurgery System
Check against the official notice below — it lists the full affected range.
Zap Surgical Systems has recalled the ZAP-X Radiosurgery System due to a software issue affecting patient setup. When there are large rotational deviations of 1.5 degrees or greater between digitally reconstructed radiographs and pre-delivery X-ray images, the system's transitional alignment algorithm may incorrectly calculate treatment table offset values, resulting in an incorrect position for the treatment isocenter. Eight units have been affected, including serial numbers ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, and ZUC21162, all running Treatment Delivery Software Version 1.8.53.
The affected devices were distributed worldwide, including in the U.S. states of Arizona, Maryland, Florida, and Colorado, as well as in Germany, Switzerland, and Japan. The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN. Quantity: 8 Lot/code info: UDI-DI: 00860183001504, Serial Numbers, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.