Z-0456-2014 Class II Terminated
FDA device recall Z-0456-2014 was initiated by Iba Dosimetry Gmbh on August 20, 2013 and is designated Class II. 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 condition… The recall status is terminated (terminated February 24, 2014). Affected quantity: 33 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2013
- Initiation Date
- August 20, 2013
- Termination Date
- February 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units
Product Description
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
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.
Distribution Pattern
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.
Code Information
SW Version 3.0. Catalong Number CS10-100