medical Class II Updated 2021-10-06

Elekta Inc recalls Elekta Monaco - Product Usage: used to make treatment plans

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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