🔍 RecallPedia

iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

Class I - Dangerous
🏥 Medical Devices Recalled: August 20, 2013 Iba Dosimetry Gmbh Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    SW Version 3.0. Catalong Number CS10-100
  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:
The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

Product Codes/Lot Numbers:

SW Version 3.0. Catalong Number CS10-100

Distribution:

Distributed in: US, CT, MA, OH, CA, SC, NY, OK, GB

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0456-2014

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.

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