Elekta MOSAIQ Oncology System Recalled for Care Plan Update Failure
Elekta is recalling MOSAIQ Oncology Information System versions 2.50.05 and higher because outdated information may remain in order sets, potentially affecting treatment workflows.
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recall involves a medical device used for cancer treatment planning where a software defect could lead to the use of outdated information. This represents a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Elekta, Inc. is recalling MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher. The recall involves 355 units distributed worldwide, including the United States and several international markets such as Australia, Canada, Germany, and the United Kingdom.
The recall was initiated due to a software defect where double-clicking to add or delete a Component/Procedure to an Order Set in the Care Plan Library does not trigger the update of associated Care Plans. This issue can result in the retention of outdated information within the system.
MOSAIQ is used by healthcare facilities to manage workflows for treatment planning and delivery for radiotherapy and/or chemotherapy. Users should contact Elekta, Inc. for further instructions regarding the software update or replacement.
The recalled product
- Product
- MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: 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 wherever…
- Manufacturer
- Elekta, Inc.
- Affected units
- 355
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)
- None
Distribution
Distributed nationwide across the United States.
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