Recall Z-0456-2014— Iba Dosimetry Gmbh
Class II · Terminated
Class II FDA medical device recall by Iba Dosimetry Gmbh, initiated 2013-08-20, terminated 2014-02-24. It names one FDA 510(k) clearance: K072374. Product: iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological. Reason: 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..
- Recalling firm
- Iba Dosimetry Gmbh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-20
- Terminated
- 2014-02-24
- Firm location
- Schwarzenbruck, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.