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U.S. Department of Health and Human Services

Class 2 Device Recall iba COMPASS SW Version 3.0

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  Class 2 Device Recall iba COMPASS SW Version 3.0 see related information
Date Initiated by Firm August 20, 2013
Date Posted December 06, 2013
Recall Status1 Terminated 3 on February 24, 2014
Recall Number Z-0456-2014
Recall Event ID 66808
510(K)Number K072374  
Product Classification Accelerator liner medical - Product Code IYE
Product iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator)

radiological
Code Information SW Version 3.0. Catalong Number CS10-100
Recalling Firm/
Manufacturer		 Iba Dosimetry Gmbh
Bahnhofstr. 5
Schwarzenbruck Germany
For Additional Information Contact W. Michael Meyer
901-386-2242
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Iba sent an Field Safety Notice on August 20, 2013, by email and letter delivered by UPS, Please distribute this notice to all those who need to be aware within your area of responsibility where the affected software have been installed (e.g. colleagues, satellites). Please maintain awareness of this notice and resulting action until we have provided you with a new software version. We would kindly ask you to acknowledge the receipt of this Field Safety Notice. Please sign and send back the attached Confirmation of Receipt within four weeks after the receipt of this Field Safety Notice. We deeply apologize for the inconvenience. We are working on a new software version with corrected functionality. This should become available during next fall and we will ship it to you as soon as it is released, together with the installation and verification instructions. Should you have questions or require additional information, please contact the Customer Service Team at: Service Department IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck, Germany Tel.:+49 9128 607 38 Fax: + 49 9128 607 26 Email: service@iba-group.com .
Quantity in Commerce 33 units
Distribution Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.
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
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