Oncentra Brachy Radiation Therapy Software Reconstruction Error
Elekta's Oncentra Brachy radiation therapy planning software may experience reconstruction errors when using Catheter Bending functionality in versions 4.0 and above.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device software with a potential error in a critical therapy-planning function. No illnesses or injuries are reported in the source, placing this at the high end of severity for a risk-of-harm product without documented patient impact.
Plain-English summary
Elekta, Inc. is recalling versions 4.0 and above of Oncentra Brachy radiation therapy planning system software that include Applicator Modeling or Implant Modeling features. The recall addresses a reconstruction error that may occur when using the Catheter Bending functionality.
Approximately 336 systems have been distributed to healthcare facilities nationwide, including Puerto Rico. Facilities using affected software versions should contact Elekta for guidance on this issue and any available corrective measures.
The recalled product
- Product
- Oncentra Brachy radiation therapy planning system software.
- Manufacturer
- Elekta, Inc.
- Affected units
- 336
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 (17)
- Version 4.0 and above with Applicator Modeling or Implant Modeling
- UDI GTIN numbers: 08717213052758
- 08717213038660
- 08717213020610
- 08717213052321
- 08717213052314
- 08717213052307
- 08717213052291
- 08717213052246
- 08717213052239
- 08717213051881
- 08717213051843
- 08717213051782
- 08717213051775
- 08717213051294
- 08717213053717
- 08717213053700.
Distribution
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