IBA Dosimetry Recalls COMPASS Software Due to Dose Calculation Errors
Iba Dosimetry Gmbh is recalling COMPASS software version 3.1 because a defect may prevent detection of dose distribution errors, potentially leading to incorrect radiation doses during treatment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that could lead to incorrect radiation dosing, which carries a risk of significant injury.
Plain-English summary
Iba Dosimetry Gmbh is recalling 124 units of COMPASS software, Model No. SW Version 3.1, catalogue number CS10-100. This software is used with medical linear accelerators for radiological treatments. The recall was initiated due to a software error that may fail to detect deviations between the reconstructed and planned dose distribution prior to treatment.
The defect poses a risk of over- or under-estimating the pretreatment delivered dose. This could result in patients receiving incorrect radiation doses during medical procedures. The affected software was distributed worldwide, including in the United States (including Guam), Germany, Austria, France, the UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.
Healthcare facilities and users of this software should contact Iba Dosimetry Gmbh for instructions on how to address the software defect. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- COMPASS, Model No. SW Version 3.1, catalogue 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)
- N/A
Distribution
Distributed in 1 state:
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