Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Reported: October 31, 2012 Initiated: August 21, 2012 #Z-0118-2013
Product Description
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
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.
Details
- Recalling Firm
- Elekta, Inc.
- Units 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.
- Location
- Norcross, GA
Frequently Asked Questions
What product was recalled? ▼
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.. Recalled by Elekta, Inc.. Units affected: 52 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2012. Severity: Moderate. Recall number: Z-0118-2013.
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