IBA COMPASS Software Recall for Erroneous Dose Statistics
IBA Dosimetry GmbH is recalling COMPASS SW Version 3.0 due to a software defect that causes erroneous dose statistics and DVHs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that generates erroneous dose statistics, representing a risk-of-harm product where specific injury reports are not stated in the source text.
Plain-English summary
IBA Dosimetry GmbH is recalling 33 units of the iba COMPASS SW Version 3.0, Catalog Number CS10-100. This software is used in medical linear accelerators for radiological purposes.
The recall was initiated after the development partner identified a problem in a software component used when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions, this defect generates too large ROI voxel volumes, which results in erroneous dose statistics and Dose-Volume Histograms (DVHs).
The affected units were distributed worldwide, including in the United States (CT, MA, OH, CA, SC, NY, and OK) and internationally in Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong, and Singapore. Users of this software should contact IBA Dosimetry GmbH for further instructions regarding the defect.
The recalled product
- Product
- iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
- Manufacturer
- Iba Dosimetry Gmbh
- Affected units
- 33
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- SW Version 3.0. Catalong Number CS10-100
Distribution
Related recalls
Same manufacturer · Iba Dosimetry Gmbh
See all →- ModeratemyQA iON dosimetry device analysis result miscalculation issue
FDA (Devices) · 2025-05-07
- HighIBA Dosimetry Lift Table Recalled for Uncontrolled Movement Risk
FDA (Devices) · 2016-01-27
- HighIba Dosimetry Recalls Compass SW Version 3.1 Medical Linear Accelerator Software
FDA (Devices) · 2015-03-04
- SevereIBA Dosimetry Recalls COMPASS Software Due to Dose Calculation Errors
FDA (Devices) · 2014-11-12
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25