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Open, Classified

ZAP-X Radiosurgery System, Model: 300150

FDA Recall Z-2639-2025 · Posted 2025-09-26

Recalling FirmZap Surgical Systems
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2025-07-25
Product Quantity17

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.

Firm 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 [email protected]

Root Cause

Software change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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