Elekta Recalls Monaco RTP System Radiation Therapy Treatment Planning System
Elekta, Inc. is recalling 72 units of the Monaco RTP System Radiation Therapy Treatment Planning System because patients must be positioned as indicated by the treatment plan.
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 used for radiation therapy planning where incorrect patient positioning could lead to harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Elekta, Inc. is recalling 72 units of the Monaco RTP System Radiation Therapy Treatment Planning System. The recall covers all versions of the Monaco system. The product is used for radiation treatment planning.
The recall was initiated because patients need to be positioned as indicated by the treatment plan. This issue affects the accuracy of the radiation therapy treatment planning process.
The affected units were distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA. Healthcare facilities and users of the Monaco RTP System should contact Elekta, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 72
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 versions of Monaco
Distribution
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