Recall Z-0050-2018— Nucletron BV
Class II · Terminated
Class II FDA medical device recall by Nucletron BV, initiated 2017-08-10, terminated 2020-11-20. It names one FDA 510(k) clearance: K132816. Product: Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.. Reason: Incorrect source step size may occur in the software plans.
- Recalling firm
- Nucletron BV
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-10
- Terminated
- 2020-11-20
- Firm location
- Veenendaal, N/A, Netherlands
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
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
Reason for recall
Incorrect source step size may occur in the software plans
Data sourced from openFDA. This site is unofficial and independent of the FDA.