Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Recall Z-2563-2021 · Posted None
Recalling FirmElekta Inc
Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2021-09-14
Product Quantity214 units
Reason for Recall
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
Firm Action
A Recall notification letter titled, "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" was sent to consignees on 09/14/2021 via email. The letter instructs the consignee of the following:
"When using Monaco in offline mode, ensure that the active image set is selected in the workspace control when using the Auto Margin tool."
The consignee is to post the notice in a place that is accessible to all users until the action is closed. Furthermore, the consignee is to advise the appropriate personnel, working with this product, on the content of the letter. The firm is requesting that the consignee submit an acknowledgement form as well via the Elekta Care" Community or complete the form and return it to Elekta immediately upon receipt, but no
later than within 30 days.
Root Cause
Software design
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.