Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ZAP-X Radiosurgery System Recalled by Zap Surgical Systems Due to Software issue identified in cases of initial patient...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zap Surgical Systems directly.
Affected Products
ZAP-X Radiosurgery System
Quantity: 8
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zap Surgical Systems
Zap Surgical Systems has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report