Recall – Radiation treatment planning system software error

Company: Elekta, Inc.
Date of Enforcement Report: 2/8/2019
Class II:

PRODUCT

Monaco Radiation Treatment Planning (RTP) System

Recall Number: Z-0965-2019

REASON

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

RECALLING FIRM/MANUFACTURER

Elekta, Inc. on 2/8/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
14 devices

DISTRIBUTION

US Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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