Zap Surgical Systems: Medical Device Recall in 2022 - (Recall #: Z-1742-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

ZAP-X Radiosurgery System

Product Classification:

Class II

Date Initiated: July 5, 2022

Date Posted: September 21, 2022

Recall Number: Z-1742-2022

Event ID: 90716

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.

Status: Ongoing

Product Quantity: 8

Code Information:

UDI-DI: 00860183001504, Serial Numbers, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated