Elekta MOSAIQ Oncology System Recalled for Dose Rounding Error
Elekta, Inc. is recalling 15 units of the MOSAIQ oncology information system because a dose rounding error may cause incorrect numeric data to be displayed on printed reports.
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 used for cancer treatment planning where a software error could lead to incorrect dose data. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 15 units of the MOSAIQ oncology information system. MOSAIQ is used to manage workflows for treatment planning and delivery, supporting information flow among healthcare facility personnel where radiotherapy and/or chemotherapy are prescribed.
The recall is due to a problem that can result in the display of incorrect numeric data on printed reports caused by a dose rounding error. The affected software version is MOSAIQ Release 2.60.257.
The product was distributed nationwide in the United States, specifically in the states of Arizona, Colorado, Illinois, Maryland, Missouri, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, Texas, and Virginia. Healthcare facilities using this system should contact Elekta, Inc. for further instructions regarding the recall.
The recalled product
- Product
- MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
- Manufacturer
- Elekta, Inc.
- Affected units
- 15
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)
- MOSAIQ Release 2.60.257
Distribution
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