Recall archive / FDA device enforcement
ZAP-X Radiosurgery System — FDA record Z-1742-2022
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 5, 2022. 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
- Reason
- Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter.
- Classification
- Class II
- Recalling firm
- Zap Surgical Systems
- Quantity
- 8
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1742-2022
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, ZUC17152, ZUC17153, ZUC18155, ZUC20157, ZUC20158, ZUC20156, ZUC21161, ZUC21162, using Treatment Delivery Software Version: 1.8.53 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AZ, MD, FL, CO and the countries of DEU, CHE, JPN.
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
- Sep 21, 2022
- Recall initiation date
- Jul 5, 2022
- Center classification date
- Sep 14, 2022
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.