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U.S. Department of Health and Human Services

Class 2 Device Recall COMPASS

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  Class 2 Device Recall COMPASS see related information
Date Initiated by Firm September 25, 2014
Date Posted November 04, 2014
Recall Status1 Terminated 3 on January 26, 2015
Recall Number Z-0168-2015
Recall Event ID 69583
510(K)Number K072374  
Product Classification Accelerator, linear, medical - Product Code IYE
Product COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Code Information N/A
Recalling Firm/
Iba Dosimetry Gmbh
Bahnhofstr. 5
Schwarzenbruck Germany
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
Action The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on 09/25/2014.
Quantity in Commerce 124 units
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, Taiwan, Hong Kong, and Malaysia.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SCANDITRONIX WELLHOFER GMBH