Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in t
FDA device recall Z-0118-2013 · posted 2012-10-23 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.
- Action taken
- Nucletron sent a Customer Information Bulletin 555.00248 to all affected customers. The bulletin identified the product, problem, and actions to be taken by the customers. The bulletin contained information on how an incorrect dose association can be prevented by not renumbering beams during recalculation. A Read Confirmation Form was included for customers to complete and return. Contact your local Nucleton Service Representative for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 52 units
- Distribution
- Nationwide Distribution-including the states of AL, CA, DC, KS, LA, MO, NB, NY, NC, ND, OH, OR, PA, RI, SC, TX, and WA.
- Date initiated
- 2012-08-21
- Date posted
- 2012-10-23
- Date terminated
- 2014-11-03
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) (K081281) | Nucletron Corporation | 2008-05-20 |