Recall Z-1712-2015— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2015-05-21, terminated 2021-07-16. It names 2 FDA 510(k) clearances: K121448, K081281. Product: Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.. Reason: Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-21
- Terminated
- 2021-07-16
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
2 on FDA's record- K121448 — ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
- K081281 — OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
K-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
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Reason for recall
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
Data sourced from openFDA. This site is unofficial and independent of the FDA.