Recall Z-1212-2015— Iba Dosimetry Gmbh
Class II · Terminated
Class II FDA medical device recall by Iba Dosimetry Gmbh, initiated 2015-02-02, terminated 2015-08-18. It names one FDA 510(k) clearance: K072374. Product: COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological. Reason: Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points..
- Recalling firm
- Iba Dosimetry Gmbh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-02
- Terminated
- 2015-08-18
- Firm location
- Schwarzenbruck, N/A, 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
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Reason for recall
Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
Data sourced from openFDA. This site is unofficial and independent of the FDA.