🔍 RecallPedia

COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

Class I - Dangerous
🏥 Medical Devices Recalled: February 2, 2015 Iba Dosimetry Gmbh Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model : SW Version 3.1 Lot or Serial Number : n.a
  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:
Iba Dosimetry Gmbh
Reason for Recall:
Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

Product Codes/Lot Numbers:

Model : SW Version 3.1 Lot or Serial Number : n.a

Distribution:

Distributed in: US, AZ, OK, UK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1212-2015

Related Recalls

myQA iON; Article Number: MQ10-000;

IBA Dosimetry GmbH

Class I - Dangerous

Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

Apr 1, 2025 Other Medical Devices Nationwide View Details →