Product Wiki · Recalls · U.S. FDA — Device Enforcement

COMPASS, Model No — recall Z-0168-2015

U.S. FDA — Device Enforcement · Germany · 2014-09-25 · Class II

As described by U.S. FDA — Device Enforcement: COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0168-2015
Date of alert
2014-09-25
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Iba Dosimetry Gmbh
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
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,
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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