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

Monaco Radiation Treatment Planning System (RTP) System — recall Z-0670-2020

U.S. FDA — Device Enforcement · United States · 2019-11-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0670-2020
Date of alert
2019-11-22
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
IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
Barcode (EAN/GTIN)
00858164002190
Reported risk: Monaco is using the incorrect energy when optimizing and calculating dose.
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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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.