Recall Z-2406-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta Inc
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
| Date | Jul 26, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Elekta will send an Important Field Safety Notice 382-01-MON-019 to all affected customers beginning August 10, 2021. The notice informs users of the specific product and version numbers affected by the issue, and any workaround that can be used to avoid the issue. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are asked to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as |
| Distribution | Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom |
| FDA record | Open on fda.gov |