Elekta MOSAIQ Oncology System Recalled for Potential Plan Selection Error
Elekta is recalling 69 MOSAIQ Oncology Information System units because scrolling the mouse wheel could accidentally change the selected treatment plan.
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 with a risk of harm (incorrect treatment plan selection) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Elekta, Inc. is recalling 69 units of the MOSAIQ Oncology Information System, versions 2.62 and higher. The recall is due to a software issue where the selected Plan-of-the-Day could be accidentally changed by scrolling the mouse wheel up and down, potentially leading to the inadvertent selection of another plan.
The affected products were distributed in the United States, including Puerto Rico, and in specific states: AK, AZ, CA, FL, GA, IL, IN, LA, MD, MI, MO, NJ, NY, OH, OR, PA, TN, TX, UT, and VA. The products were also distributed in Canada, Denmark, Finland, Germany, Israel, Japan, the Netherlands, Norway, Sweden, and the United Kingdom.
Healthcare facilities using this system should contact Elekta for instructions on how to address the issue. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- MOSAIQ Oncology Information System
- Manufacturer
- Elekta, Inc.
- Affected units
- 69
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)
- Versions 2.62 and higher
Distribution
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