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Recall Observatory FDA recall evidence

Device product

Monaco Radiation Treatment Planning System (RTP) System

Z-2409-2019

August 23, 2019

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 83604
Status
Terminated
Classification
Class II
Quantity
49 units
Official record key
device-enforcement:Z-2409-2019

Official wording

Reason: Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.

Code information: Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00

Distribution pattern: Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.