Recall – Treatment planning system software error under certain conditions

Company: Elekta Inc
Date of Enforcement Report: 9/8/2021
Class II

PRODUCT

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Recall Number: Z-2406-2021

REASON

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

RECALLING FIRM/MANUFACTURER

Elekta Inc on 7/26/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

NA

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

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