Reported Oct 8, 2025 · Ongoing
ZAP-X Radiosurgery System, Model: 300150
Zap Surgical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zap Surgical Systems · 590 Taylor Way · San Carlos, CA · 94070-6307
Is this the product you have?
- ZAP-X Radiosurgery System
- Model300150
- Lot codes and dates
- UDI-DI00860183001504
- Serial Numbers
ZUC17153ZUC20156ZUC20157ZUC20159ZUC21162ZUC21164ZUC22166ZUC22169ZUC22170ZUC22171ZUC22173ZUC22174ZUC23176ZUC23177ZUC24179ZUC24180ZUC24181
- Software versionTDS V1.10.1
- Amount recalled
- 17
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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