| Class 2 Device Recall iba COMPASS SW Version 3.0 | |
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
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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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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