FDAFDA · Food and drugs·Recall number Z-2277-2013
Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
Published October 2, 2013 · Recall initiated: May 22, 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
Patient needs to be positioned as indicated by the treatment plan.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.
- Lot
- All versions of Monaco
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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