ZAP-X Radiosurgery System, Model: 300150 recallZ-2639-2025 · Zap Surgical Systems · initiated Jul 25, 2025
Class II Open, Classified All recalls posted in September 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zap Surgical Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software change control
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-2639-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 25, 2025
- Posted by the FDA
- Sep 26, 2025
- Recalling firm
- Zap Surgical Systems
- Quantity
- 17
- Product code
- IYE
- FDA submissions
- K211663
- 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.
Product description
ZAP-X Radiosurgery System, Model: 300150
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zap-X Radiosurgery System 300150Zap Surgical Systems, Inc. · Accelerator, Linear, Medical2 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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