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U.S. Department of Health and Human Services

Class 2 Device Recall COMPASS SW Version 3.1, Catalog Number CS10100

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  Class 2 Device Recall COMPASS SW Version 3.1, Catalog Number CS10100 see related information
Date Initiated by Firm February 02, 2015
Date Posted February 26, 2015
Recall Status1 Terminated 3 on August 18, 2015
Recall Number Z-1212-2015
Recall Event ID 70545
510(K)Number K072374  
Product Classification Accelerator, linear, medical - Product Code IYE
Product COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Code Information Model : SW Version 3.1  Lot or Serial Number : n.a
Recalling Firm/
Manufacturer		 Iba Dosimetry Gmbh
Bahnhofstr. 5
Schwarzenbruck Germany
For Additional Information Contact W. Michael Meyer
901-386-2242
Manufacturer Reason
for Recall		 Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action IBA sent an Field Safety Notice dated January 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Please do not use the dose reconstruction function COMPASS 3.1 and 3.1a for DMLC plans from Monaco or Eclipse -11 when the jaws move or MLC leaves reverse during beam on. A correct Version ( COMPASS 3.1b) will be delivered as soon as it is available. The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on February 2, 2015. Should you have questions or require additional information, please contact the Customer Service Team at South and Middle America, USA and Canada - Phone. +1 901.386.2246 Asia Pacific, Australia and New Zealand - Phone. +86 10 8080 9107 All other countries - Phone. 49 9128 607 - 38
Quantity in Commerce 124 units
Distribution Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.
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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