Recall- Software Issue May Lead to Incorrect Positions for X-Rays & Radiographs

Company: Zap Surgical Systems

Date of Enforcement Report: 9/14/2022

Class II


ZAP-X Radiosurgery System

Recall Number:



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




Worldwide distribution – US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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