Zap Surgical Systems recalled 17 ZAP-X Radiosurgery System units worldwide, including US states FL, CO, NJ, NY and several countries. A software defect could cause the collimator to collide with patient shoulders or the patient table during long gantry moves after proximity errors. Clinicians and patients should stop using the device and follow recall instructions from the manufacturer.
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 ZAP-X Radiosurgery System is a professional medical device used in radiosurgical treatments. It is designed for precise, targeted radiation therapy. This device operates in a clinical setting under physician supervision.
A software defect may trigger a proximity error during extensive gantry movement. If a second proximity error occurs after automatic speed reduction, the collimator could collide with the patient or the table, causing potential injury.
This recall is not part of a broader industry pattern.
Hospitals and clinics must pause use of affected devices, assess patient schedules, and coordinate with the manufacturer for guidance on patient safety and device remediation.
UDI-DI and serial numbers are located on the device label and in the hospital asset management system.
Specific remediation timeline not provided in the notice.
Keep a copy of the recall notice, serial numbers, UDI, and correspondence with the manufacturer.
Brand: Zap Surgical Systems Product: ZAP-X Radiosurgery System Model: 300150 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 Sold worldwide with US states FL, CO, NJ, NY and countries Germany, France, Spain, Poland, Republic of Korea, Türkiye, Paraguay Price: Unknown
No injuries or incidents have been reported.
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