High FDA (Devices)·Z-0719-2023·Announced 2022-12-21

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.

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 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.
Category: Medical Device — Radiation Therapy Software
Hazard: reconstruction-error
software-malfunction
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Elekta, Inc.

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