Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
COMPASS Recalled by Iba Dosimetry Gmbh Due to Error in the software. A deviation between reconstructed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Iba Dosimetry Gmbh directly.
Affected Products
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Quantity: 124 units
Why Was This Recalled?
Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.
Where Was This Sold?
Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.
About Iba Dosimetry Gmbh
Iba Dosimetry Gmbh has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report