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Open, Classified

Monaco Radiation Treatment Planning System (RTP) System

FDA Recall Z-0670-2020 · Posted None

Recalling FirmElekta Inc
Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2019-11-22
Product Quantity76 (7 US, 69 OUS)

Reason for Recall

Monaco is using the incorrect energy when optimizing and calculating dose.

Firm Action

An Important Field Safety Notification letter is being emailed to affected customers beginning 11/22/2019. The letter identifies affected product, provides a description of the problem, and recommends user not use multiple energies within the same plan until a software fix has been applied to the device. A response form was asked to be returned. Affected customers are advised to contact local Elekta service teams for questions.

Root Cause

Software Design Change

Distribution Pattern

IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190178Monaco RTP SystemElekta, Inc. · 2019-03-29K183037Monaco RTP SystemElekta, Inc. · 2018-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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