Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Reported: May 6, 2020 Initiated: April 16, 2020 #Z-1825-2020
Product Description
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Reason for Recall
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Details
- Recalling Firm
- Elekta Inc
- Units Affected
- 96 devices
- Distribution
- Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.
- Location
- Saint Charles, MO
Frequently Asked Questions
What product was recalled? ▼
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The. Recalled by Elekta Inc. Units affected: 96 devices.
Why was this product recalled? ▼
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1825-2020.
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