Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model 1.1
  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:
Elekta, Inc.
Reason for Recall:
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.

Product Codes/Lot Numbers:

Model 1.1

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1083-2014

Related Recalls

Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound

Sep 30, 2025 Surgical Instruments Nationwide View Details β†’