Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0076-2017 — Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patien

U.S. FDA — Device Enforcement · United States · 2016-09-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0076-2017
Date of alert: 2016-09-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Elekta, Inc.
Product category: device
Product type: Devices

Reported risk: When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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