🔍 RecallPedia

Oncentra Brachy radiation therapy planning system software.

Class I - Dangerous
🏥 Medical Devices Recalled: December 5, 2022 Elekta Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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, 08717213020610, 08717213053717, 08717213053700.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Elekta, Inc.
Reason for Recall:
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Oncentra Brachy radiation therapy planning system software.

Product Codes/Lot Numbers:

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, 08717213020610, 08717213053717, 08717213053700.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0719-2023

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Class I - Dangerous

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