FDAFDA · Food and drugs·Recall number Z-1088-2015
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Published February 18, 2015 · Recall initiated: January 7, 2015
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
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- Worldwide Distribution - USA including AZ, CA, FL, KS, LA, MN, MO, NY, NC and Internationally to Austria, Bulgaria, Canada, China, Germany, Hungary, Italy, Malaysia, Malta, Netherlands, Norway, Russia, Spain, Sweden, Taiwan and Ukraine.
- Lot
- 153602, 153538, 153561, 153569, 153532, 153556, 153566, 153563, 153564, 153589, 153530, 153531, 153562, 153584, 153615, 153534, 153534, 153535, 153563, 153542, 153542, 153548, 153548, 153558, 153578, 153595, 153699, 153630, 153728, 153680, 153712. 153717, 153723, 153734, 153702, 153715, 153684, 153710, 153577, 153725, 153726, 153691, 153696, 153713, 153724, 153727
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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