ZAP-X Radiosurgery System, Model: 300150
FDA device recall Z-2639-2025 · posted 2025-09-26 · Open, Classified
Recall details
- Recalling firm
- Zap Surgical Systems
- Reason for recall
- 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.
- Action taken
- 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 the gantry to its home position before resuming any treatment procedures. If you have any further questions related to this situation email Derek@zapsurgical.com
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- IYE
- Quantity affected
- 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.
- Date initiated
- 2025-07-25
- Date posted
- 2025-09-26
- Location
- San Carlos, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Zap-X Radiosurgical System (K211663) | Zap Surgical Systems, Inc. | 2021-07-29 |