Recall Z-2091-2019— Elekta Inc
Class II · Ongoing
Class II FDA medical device recall by Elekta Inc, initiated 2019-07-03. It names one FDA 510(k) clearance: K151233. Product: Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System. Reason: When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly..
- Recalling firm
- Elekta Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-07-03
- Firm location
- Maryland Heights, 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
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Reason for recall
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.