Elekta Monaco RTP System Recalled for Incorrect Dose Calculation Errors
Elekta, Inc. is recalling the Monaco RTP System because editing beam numbers and wedge angles can result in incorrect dose calculations for radiation therapy patients.
What this means for you
Illness, injury, or structural failure has been reported. 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 defect that can lead to incorrect radiation doses, which is a significant injury risk for patients undergoing radiation therapy.
Plain-English summary
Elekta, Inc. is recalling the Monaco RTP System, a software system used to create treatment plans for patients prescribed external beam radiation therapy. The recall is due to a defect where editing the beam number and wedge angle can lead to an incorrect dose calculation.
The affected software builds include V 5.10.00 (including 5.10.01, 5.10.02), V 5.11.00 (including 5.11.01), and V 5.20.00. The recall covers 1,999 units distributed across numerous U.S. states and international locations, including Puerto Rico, Canada, and various countries in Europe, Asia, Africa, and South America.
This is a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. Healthcare providers using this software should contact Elekta, Inc. for further instructions on how to address the defect and ensure patient safety.
The recalled product
- Product
- Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Manufacturer
- Elekta, Inc.
- Affected units
- 1,999
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 (4)
- Software Builds - V 5.10.00 (including 5.10.01
- 5.10.02)
- V 5.11.00 (including 5.11.01)
- V 5.20.00
Distribution
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