medical MODERATE Updated 2022-12-21

Elekta, Inc. recalls Oncentra Brachy radiation therapy planning system software.

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Recalled Product

Oncentra Brachy radiation therapy planning system software.

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Hazard / Issue

A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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