medical MODERATE Updated 2017-09-13

Elekta, Inc. recalls MOSAIQ Medical Charged-Particle Radiation Therapy System

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Recalled Product

MOSAIQ Medical Charged-Particle Radiation Therapy System

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Hazard / Issue

The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.

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.
View official government recall