Recall Z-0076-2017— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2016-09-29, terminated 2021-07-16. It names one FDA 510(k) clearance: K151233. Product: Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups. Reason: When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-29
- Terminated
- 2021-07-16
- Firm location
- Atlanta, GA, 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 The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
Reason for recall
When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.