medical MODERATE Updated 2023-03-15

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

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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

Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03; UDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01, (01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03

✅ 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. →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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