Recall Z-2563-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta Inc
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
| Date | Sep 14, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| 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 s |
| Quantity | 214 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |