ZAP-X Radiosurgery System Software Defect May Cause Collision
A software defect in the ZAP-X radiosurgery system could cause the collimator to collide with patient shoulders or the treatment table during certain gantry movements.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a risk-of-harm medical device. While the software defect creates potential for patient injury during treatment through collimator collision with anatomy, no illnesses or injuries have been reported.
Plain-English summary
The ZAP-X Radiosurgery System, Model 300150, manufactured by Zap Surgical Systems, is being recalled due to a software defect identified in 17 units distributed worldwide.
A software defect can occur when the system experiences a proximity error message during a long gantry move (greater than 180 degrees). If a subsequent proximity error occurs after the automatic speed reduction is activated, the software may fail to prevent the collimator from colliding with patient shoulders or the treatment table.
The affected units have been distributed in the United States (Florida, Colorado, New Jersey, and New York) and internationally in Germany, France, Spain, Poland, Republic of Korea, Turkey, and Paraguay. The specific affected serial numbers are ZUC17153, ZUC20156, ZUC20157, ZUC20159, ZUC21162, ZUC21164, ZUC22166, ZUC22169, ZUC22170, ZUC22171, ZUC22173, ZUC22174, ZUC23176, ZUC23177, ZUC24179, ZUC24180, and ZUC24181, running software version TDS V1.10.1.
Healthcare facilities with affected equipment should contact Zap Surgical Systems for information on addressing this defect.
The recalled product
- Product
- ZAP-X Radiosurgery System, Model: 300150
- Manufacturer
- Zap Surgical Systems
- Hazard
- software-defect
- collision
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03