FDAFDA · Food and drugs·Recall number Z-0456-2014
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Published December 18, 2013 · Recall initiated: August 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Iba Dosimetry Gmbh
- Distributor
- 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.
- Lot
- SW Version 3.0. Catalong Number CS10-100
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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