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FDAFebruary 28, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

elekta

UPCs

00858164002169

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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