San Carlos, CA, United States
Zap Surgical Systems recalls
2 recalls recorded since 2018, most recently on 25 July 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 July 2025
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2639-2025
- ZAP-X Radiosurgery System, Model: 300150
Ongoing Class II Medical devices
- Recall started
- 5 July 2022
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1742-2022
- ZAP-X Radiosurgery System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.