Reported Dec 18, 2013 · Terminated
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Iba Dosimetry GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Iba Dosimetry Gmbh · Bahnhofstr. 5 · Schwarzenbruck · N/A
Is this the product you have?
- iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
- Lot codes and dates
- SW Version 3.0. Catalong Number CS10-100
- Amount recalled
- 33 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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