FDA Device recall Z-1712-2015
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose o…
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose o… by Elekta, citing incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1712-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-21 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV |
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.
Identifiers
| code_info | MUJ/892.5050, Software Builds - 3.3, 4.0, 4.1, 4.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1712-2015%22
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