Recall Z-1742-2022 ยท IYE Accelerator, Linear, Medical
Zap Surgical Systems
ZAP-X Radiosurgery System
| Date | Jul 5, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | On 7/05/22 correction notices were distributed to customers who were told that revised software to address the recall issue would be supplied. Until the firm supplies the revised software follow the following steps to ensure accurate treatment delivery: 1) After using auto-align ensure initial patient setup (prior to treating the first isocenter), has rotational deviations of less than plus-minus 1.5 degrees in each dimension. 2) Prior to commencement of each isocenter beam delivery, verify that rotational deviations remain below plus-minus 1.5 degrees. - Additionally, visually verify patien |
| Quantity | 8 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211663 | Zap-X Radiosurgical System Zap Surgical Systems, Inc., Jul 29, 2021 |