medical MODERATE Updated 2017-01-25

Elekta, Inc. recalls Monaco RTP System. Used to make treatment plans for patie

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Recalled Product

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

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Hazard / Issue

Incorrect dose after editing beam number an wedge angle.

Issued by

FDA

Affected States: AZ, AR, CA, CO, GA, IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI
Lot/Code Info: Software Builds - V 5.10.00 (including 5.10.01, 5.10.02); V 5.11.00 (including 5.11.01); V 5.20.00

✅ 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.

Looking for a safe alternative?

Search Amazon for Monaco RTP System. →
View official government recall