Elekta Monaco RTP System Recalled for Incorrect Wedge Calculations
Elekta is recalling 279 Monaco RTP Systems because they may calculate Enhanced Dynamic Wedge or Virtual Wedge values incorrectly.
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 the hazard involves incorrect calculations for radiation therapy treatment plans, which poses a significant risk of patient injury if not corrected.
Plain-English summary
Elekta, Inc. is recalling 279 units of the Monaco RTP System. This software is used to create treatment plans for patients prescribed external beam radiation therapy. The recall involves software versions 5.00 and higher.
The recall was initiated because the system may produce incorrect calculations for Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW). These errors could affect the accuracy of the radiation treatment plans generated by the software.
The affected units were distributed worldwide, including in the United States (California, Indiana, Kentucky, Massachusetts, New Jersey, New York, North Carolina, Pennsylvania, Texas, and Wisconsin) and in Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, the Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, and Turkey. Healthcare providers using this software should contact Elekta for further instructions on how to address the calculation errors.
The recalled product
- Product
- Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Manufacturer
- Elekta, Inc.
- Affected units
- 279
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 Versions 5.00 and higher
Distribution
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