Zap Surgical Systems Recall 90716
Description: ZAP-X Radiosurgery System
Zap Surgical Systems Recall 90716 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1742-2022 |
| Event ID | 90716 |
| Event Description | ZAP-X Radiosurgery System |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN. |
| Quantity | 8 |
| Recall Reason | 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. |
| Device Classification | 20220921 |
| Device Code Info | UDI-DI: 00860183001504, Serial Numbers, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53 |
| Center Classification Date | 20220914 |
| Recall Initiation Date | 20220705 |
| Recalling Firm | Zap Surgical Systems |
| Initial Notification | Letter |
| Similar To |