Home / Recalls / Zap Surgical Systems / Z-1742-2022

Z-1742-2022 Class II Ongoing

Recalled by Zap Surgical Systems — San Carlos, CA

Recall Details

Product Type: Devices
Report Date: September 21, 2022
Initiation Date: July 5, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8

Product Description

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 Pattern

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

Code Information

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