FDAFDA · Food and drugs·Recall number Z-0841-2013
Monaco RTP System. Radiation treatment planning.
Published February 27, 2013 · Recall initiated: February 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
- Lot
- Versions 3.20.00 and 3.20.01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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