🔍 RecallPedia

ZAP-X Radiosurgery System, Model: 300150

Class I - Dangerous
🏥 Medical Devices Recalled: July 25, 2025 Zap Surgical Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Zap Surgical Systems
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

ZAP-X Radiosurgery System, Model: 300150

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2639-2025

Related Recalls

ZAP-X Radiosurgery System

Zap Surgical Systems

Class I - Dangerous

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.

Jul 5, 2022 Other Medical Devices Nationwide View Details →