Recall Z-1825-2020— Elekta Inc
Class II · Ongoing
Class II FDA medical device recall by Elekta Inc, initiated 2020-04-16. It names one FDA 510(k) clearance: K183037. Product: 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: 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..
- Recalling firm
- Elekta Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-04-16
- Firm location
- Saint Charles, MO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.