FDA recall Z-1742-2022

Product

ZAP-X Radiosurgery System

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.

Key facts

Status

Ongoing

Initiation date

2022-07-05

Report date

2022-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Carlos, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1742-2022