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Recall Observatory FDA recall evidence

Device product

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

Z-2563-2021

September 14, 2021

Class II

Product summary

Firm
Elekta Inc
Event
Event 88676
Status
Ongoing
Classification
Class II
Quantity
214 units
Official record key
device-enforcement:Z-2563-2021

Official wording

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.

Code information: Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002190(10) 5.40.01, (01)00858164002190(10) 5.40.02, (01)00858164002268(10) 5.51.10

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.