Brachytherapy Planning Software Dose Calculation Discrepancy
Elekta's Oncentra Brachy versions 4.0+ may calculate incorrect doses for two-channel ovoid applicators in certain circumstances. Approximately 1,072 devices distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is FDA Class II with no reported illnesses or injuries. However, a dosing calculation error in cancer brachytherapy planning is a risk-of-harm product where injury has not yet been reported, matching the rubric criterion for Score 3 (High).
Plain-English summary
Elekta, Inc. is recalling Oncentra Brachy versions 4.0 and above with Applicator Modeling license 170283-00. Under certain circumstances, the software can produce a difference between the planned and delivered dose for the two ovoid applicator channels.
Approximately 1,072 devices have been distributed throughout the United States and to more than 50 countries worldwide.
Users should contact Elekta, Inc. for instructions regarding this recall.
The recalled product
- Product
- Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
- Manufacturer
- Elekta, Inc.
- Affected units
- 1,072
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 08717213038660
- 08717213020610
- 08717213052321
- 08717213052314
- 08717213052307
- 08717213052291
- 08717213052246
- 08717213052239
- 08717213051881
- 08717213051843
- 08717213051782
- 08717213051775
- 08717213051294
- 08717213053717
- 08717213053700
Distribution
Distribution scope not specified by the agency.
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