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Recall Observatory FDA recall evidence

Device product

Monaco RTP System. Radiation treatment planning.

Z-0841-2013

February 11, 2013

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 64328
Status
Terminated
Classification
Class II
Quantity
13
Official record key
device-enforcement:Z-0841-2013

Official wording

Reason: The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.

Code information: Versions 3.20.00 and 3.20.01

Distribution pattern: Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.