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

Monaco RTP System, 5.40 Unity, radiation treatment planning system — recall Z-2560-2019

U.S. FDA — Device Enforcement · United States · 2019-09-04 · Class II

As described by U.S. FDA — Device Enforcement: Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-sc

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2560-2019
Date of alert
2019-09-04
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Elekta Inc
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
Barcode (EAN/GTIN)
00858164002190
Reported risk: It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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