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

Recall Z-2712-2016 — Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

U.S. FDA — Device Enforcement · United States · 2016-08-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2712-2016
Date of alert
2016-08-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Elekta, Inc.
Product category
device
Product type
Devices
Reported risk: In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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