Zap Surgical Systems recalled 17 ZAP-X Radiosurgery Systems on July 25, 2025. A software defect may cause the collimator to collide with patients during operation. Healthcare providers should stop using the device immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Zap Surgical Systems or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the ZAP-X Radiosurgery System, Model 300150. It is distributed worldwide, including states such as Florida, Colorado, New Jersey, and New York, and countries like Germany, France, and South Korea. The device's serial numbers include ZUC17153 through ZUC24181, with a specific software version of TDS V1.10.1.
The radiosurgery system may trigger a proximity error during a long gantry move. This defect could lead the collimator to collide with the patient's shoulders or the patient table, posing a serious risk of injury.
No specific incidents or injuries have been reported yet. However, the potential for collision presents a significant risk to patients.
Stop using the ZAP-X Radiosurgery System immediately. Follow the recall instructions provided by Zap Surgical Systems and contact your healthcare provider for further guidance.
For more information, visit the recall page at the FDA website or contact Zap Surgical Systems directly.
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