Recall archive / FDA device enforcement
ZAP-X Radiosurgery System, Model: 300150 — FDA record Z-2639-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ZAP-X Radiosurgery System, Model: 300150
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Zap Surgical Systems
- Quantity
- 17
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2639-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the countries of Germany, France, Spain, Poland, Republic of Korea, T¿rkiye, Paraguay.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 8, 2025
- Recall initiation date
- Jul 25, 2025
- Center classification date
- Sep 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.