FDA Medical Device Recalls (openFDA)
Zap Surgical Systems: ZAP-X Radiosurgery System, Model: 300150
- Recall number
- Z-2639-2025
- Recalling firm
- Zap Surgical Systems
- Product
- ZAP-X Radiosurgery System, Model: 300150
- Status
- Open, Classified
- Initiated
- 2025-07-25
- Posted
- 2025-09-26
- Terminated
- not on file
- 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 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
- 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.
- Lot, serial or model codes
- UDI-DI: 00860183001504, Serial Numbers: ZUC17153, ZUC20156, ZUC20157, ZUC20159, ZUC21162, ZUC21164, ZUC22166, ZUC22169, ZUC22170, ZUC22171, ZUC22173, ZUC22174, ZUC23176, ZUC23177, ZUC24179, ZUC24180, ZUC24181. Software version: TDS V1.10.1
- 510(k) numbers
- ["K211663"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3012039133
- Firm city
- San Carlos
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28