Recall Z-0112-2016— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2015-09-15, terminated 2017-04-04. It names one FDA 510(k) clearance: K151233. Product: Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Reason: Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-15
- Terminated
- 2017-04-04
- 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 Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for recall
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
Data sourced from openFDA. This site is unofficial and independent of the FDA.