medical MODERATE Updated 2017-01-18

Elekta, Inc. recalls Oncentra External Beam Oncentra Brachy Product Usage: On

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Recalled Product

Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.

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Hazard / Issue

Cross profile for Varian 60 degree wedge shows "horns."

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All software builds

✅ 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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