Elekta Recalls MOSAIQ Oncology System Due to Potential Dosing Errors
Elekta is recalling 383 units of the MOSAIQ Oncology Information System because a software issue may prevent order changes from saving, potentially resulting in incorrect chemotherapy doses.
What this means for you
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 defect that can lead to incorrect chemotherapy dosing, a risk of serious harm, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 383 units of the MOSAIQ Oncology Information System, versions 2.50.05 and higher. The recall is due to a software defect where changes to an Order Set may not be saved in the currently open Care Plan. This failure can result in an incorrect chemotherapy dose being ordered for a patient.
The affected products were distributed worldwide, including in the United States, Antigua and Barbuda, Australia, Austria, the Bahamas, Bahrain, Canada, the Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and the United Kingdom. The source text does not specify specific dates of distribution or installation.
Healthcare facilities using the MOSAIQ Oncology Information System should contact Elekta, Inc. for instructions on how to resolve the issue. The source text does not provide specific contact details or remediation steps.
The recalled product
- Product
- MOSAIQ Oncology Information System
- Manufacturer
- Elekta, Inc.
- Affected units
- 383
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 2.50.05 and higher
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Elekta, Inc.
See all →- SevereFletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
FDA (Devices) · 2026-07-15
- SevereBrachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
FDA (Devices) · 2026-07-15
- SevereElekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk
FDA (Devices) · 2026-07-15
- HighMOSAIQ oncology software may fail to load adapted treatment plan
FDA (Devices) · 2026-06-17
- HighLeksell Vantage Arc System locking mechanism may not secure properly
FDA (Devices) · 2026-05-06
Same hazard · medication error
See all →- HighIV Administration Sets from Windstone Medical for Infusion Pump Systems
FDA (Devices) · 2026-04-29
- HighMedline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks
FDA (Devices) · 2026-02-25
- HighBD Pyxis Medication Dispensing Systems Software Sync Error Recall
FDA (Devices) · 2025-03-26
- ModeratePrescription statin LIVALO tablets recalled due to foreign tablets in bottles
FDA (Drugs) · 2025-03-19
- HighPyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities
FDA (Devices) · 2025-02-19