FDAFDA · Food and drugs·Recall number Z-2002-2012
Focal SIM Planning of radiation therapy
Published July 18, 2012 · Recall initiated: June 21, 2012
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
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.
- Lot
- Version 4.64.00 - 4.700, inclusive
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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