Recall Z-2639-2025 · IYE Accelerator, Linear, Medical
Zap Surgical Systems
ZAP-X Radiosurgery System, Model: 300150
| Date | Sep 26, 2025 (initiated Jul 25, 2025) |
| Status | Open, Classified |
| Reason | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table. |
| Root cause | Software change control |
| Action | On 7/25/2025, correction notices were sent to customers who were asked to do the following: Firm will be revising the software to address this issue. Until we supply you with the revised software, the firm strongly advises that you follow these steps to prevent potential collisions. 1. In the rare event that the system triggers a proximity error message during a long gantry move (greater-than-180-degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, please manually extract the patient. 2. After the patient has been safely extracted, please return t |
| Quantity | 17 |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the countries of Germany, France, Spain, Poland, Republic of Korea, T¿rkiye, Paraguay. |
| 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 |