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Recall Observatory FDA recall evidence

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

January 07, 2015

Class II

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

    reason.no_named_rule · v1.0.0

    Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.