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

Is my product affected?

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

• UPC 00858164002190
• UPC 00858164002268

Check against the official notice below — it lists the full affected range.

What happened

Elekta Inc. is recalling its Monaco software used to create radiation treatment plans for external beam radiation therapy patients. The software has a defect where contour changes (adjustments to treatment area boundaries) can be saved to the wrong image set, and when this occurs, the dose is not properly frozen on the associated treatment plans.

The recall affects 214 units worldwide, including systems in nine U.S. states (Pennsylvania, Michigan, Wisconsin, New York, Tennessee, New Jersey, Iowa, Texas) and twelve other countries. The affected software builds are versions 5.40.00, 5.40.01, 5.40.02, and 5.51.10. The source document does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Quantity: 214 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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