Elekta MOSAIQ Oncology System Recalled for Dose Calculation Error
Elekta, Inc. is recalling MOSAIQ oncology information system software because it fails to recalculate agent volume when users change the ordering dose.
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 calculation error could lead to incorrect dosing, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Elekta, Inc. is recalling MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. The software supports information flow among healthcare facility personnel and is used where radiotherapy and/or chemotherapy are prescribed.
The recall is due to a software defect where MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose to a value other than what was initially calculated, prior to saving the order. This issue affects released builds 2.50.04D5 and higher.
The recall involves 101 units distributed worldwide, including the United States (nationwide, including Puerto Rico and specific states) and the countries of Australia, Canada, New Zealand, and the United Kingdom. Healthcare facilities using this software should contact Elekta, Inc. for further instructions on resolving the issue.
The recalled product
- Product
- MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.
- Manufacturer
- Elekta, Inc.
- Affected units
- 101
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)
- Released builds 2.50.04D5 and higher
Distribution
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