FDA recall Z-2563-2021

Elekta Inc · Class II · device

Product

Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.

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.

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.

Key facts

Status
Ongoing
Initiation date
2021-09-14
Report date
2021-10-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Charles, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2563-2021