medical MODERATE Updated 2017-01-18

Elekta, Inc. recalls Monaco RTP System Product Usage: Used to make treatment

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Recalled Product

Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

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Hazard / Issue

Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Versions 5.00 and higher

✅ 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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