Zap Surgical Systems: Medical Device Recall in 2025 - (Recall #: Z-2639-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

ZAP-X Radiosurgery System, Model: 300150

Product Classification:

Class II

Date Initiated: July 25, 2025

Date Posted: October 8, 2025

Recall Number: Z-2639-2025

Event ID: 97413

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 17

Code Information:

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 Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated