Device product
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Z-1088-2015
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 70279
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46
- Official record key
device-enforcement:Z-1088-2015
Official wording
Reason: Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Unknown
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.