FDAFDA · Food and drugs·Recall number Z-2276-2013
Monaco RTP System Radiation treatment planning
Published October 2, 2013 · Recall initiated: July 2, 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
Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.
- Lot
- Versions 3.10.00 and later
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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