iba COMPASS SW Version 3.0 recall
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Why was iba COMPASS SW Version 3.0 recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SW Version 3.0. Catalong Number CS10-100
- Product
- iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
- Recalling firm
- Iba Dosimetry Gmbh
- Quantity
- 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.
- Recall date
- December 18, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)