Elekta MOSAIQ Medical Record System Recalled for Treatment Data Error
Elekta, Inc. is recalling MOSAIQ electronic medical record systems because a user error led to a patient being seriously mistreated.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that a patient was 'seriously mistreated,' which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4 (Severe).
Plain-English summary
Elekta, Inc. is recalling MOSAIQ, an image-enabled electronic medical record system used for oncology workflow management. The recall involves 300 units of the software, specifically versions 2.00 through 2.41. The product was distributed nationwide in the United States and in Canada.
The recall was initiated after a patient was seriously mistreated following an inadvertent change to a treatment field definition in the system. A user made and saved this change, which resulted in the adverse outcome. The system allows users to manage patient charts, care plans, diagnostic tests, and medication prescriptions.
This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences. Consumers and healthcare providers should contact Elekta, Inc. for further instructions on how to address the issue.
The recalled product
- Product
- MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view…
- Manufacturer
- Elekta, Inc.
- Affected units
- 300
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)
- Version 2.00 to 2.41
Distribution
Distributed nationwide across the United States.
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