Z-1742-2022 Class II Ongoing
FDA device recall Z-1742-2022 was initiated by Zap Surgical Systems on July 5, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 8.
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