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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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