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

Recall Z-0668-2017 — Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

U.S. FDA — Device Enforcement · United States · 2016-11-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0668-2017
Date of alert
2016-11-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Elekta, Inc.
Product category
device
Product type
Devices
Reported risk: Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
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.