Elekta MOSAIQ Radiation Therapy System Recalled for Vertical Table Shift Error
Elekta is recalling the MOSAIQ Medical Charged-Particle Radiation Therapy System because a software error inverts vertical table shifts, potentially directing therapy to incorrect areas.
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 recall is classified as FDA Class II and involves a medical device defect that may direct radiation therapy to an incorrect area, posing a risk of significant injury.
Plain-English summary
Elekta, Inc. is recalling the MOSAIQ Medical Charged-Particle Radiation Therapy System. The recall involves 2,461 units distributed worldwide, including nationwide distribution in the United States and territories.
The recall is due to a software defect where the table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). This error may cause therapy to be directed to an incorrect area.
The recall covers all software builds of the affected system. Consumers and healthcare facilities should contact Elekta, Inc. for further instructions regarding the recall and necessary corrective actions.
The recalled product
- Product
- MOSAIQ Medical Charged-Particle Radiation Therapy System
- Manufacturer
- Elekta, Inc.
- Affected units
- 2,461
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)
- All software builds.
Distribution
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