Iba Dosimetry Recalls Compass SW Version 3.1 Medical Linear Accelerator Software
Iba Dosimetry GmbH is recalling Compass SW Version 3.1 software for medical linear accelerators due to a dose reconstruction error.
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 error that affects dose calculation, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Iba Dosimetry GmbH is recalling Compass SW Version 3.1, Catalog Number CS10-100, which is software for medical linear accelerators. The recall involves 124 units distributed worldwide, including the United States (Arizona and Oklahoma) and numerous international locations.
The recall was initiated because internal tests of the current development version revealed an error in the software. Specifically, dose reconstruction for DMLC plans is not scaled correctly for all control points when the jaws move or MLC leaves reverse during beam on.
The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall, nor does it report any injuries or illnesses associated with this software error.
The recalled product
- Product
- COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
- Manufacturer
- Iba Dosimetry Gmbh
- Affected units
- 124
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)
- Model : SW Version 3.1 Lot or Serial Number : n.a
Distribution
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