Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimension
FDA device recall Z-1712-2015 · posted 2015-06-04 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
- Action taken
- Important User Notice, 806-03-BTP-001, was distributed to customers on 5/21/2015, A software patch is in development and is expected to be released end of November, 2015. Elekta service will work with customers to implement the patch on affected devices within 6 months of the patch release.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 351
- Distribution
- AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh
- Date initiated
- 2015-05-21
- Date posted
- 2015-06-04
- Date terminated
- 2021-07-16
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY (K121448) | Elekta Inc. D/B/A Nucletron Corporation | 2012-07-02 |
| OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) (K081281) | Nucletron Corporation | 2008-05-20 |