Elekta Monaco RTP System Recalled for Incorrect Dose Calculation
Elekta is recalling 671 Monaco RTP Systems because the reset function may calculate an incorrect dose for external beam radiation therapy plans.
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 could result in incorrect radiation dosing, posing a risk of significant injury to patients.
Plain-English summary
Elekta, Inc. is recalling 671 units of the Monaco RTP System, a software system used to create treatment plans for patients prescribed external beam radiation therapy. The recall affects software builds 5.11 and 5.20.
The recall is being issued because the system may calculate an incorrect dose when the reset function is used. This defect could impact the accuracy of treatment plans for patients undergoing radiation therapy.
The affected units were distributed to facilities in 27 U.S. states and numerous international locations, including Canada, the United Kingdom, Germany, and Japan. Healthcare providers should contact Elekta for further instructions on how to address the software defect.
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
- 671
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)
- Software Builds 5.11 and 5.20
Distribution
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