Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1088-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Product Classification:

Class II

Date Initiated: January 7, 2015

Date Posted: February 18, 2015

Recall Number: Z-1088-2015

Event ID: 70279

Reason for Recall:

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

Status: Terminated

Product Quantity: 46

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.

Voluntary or Mandated:

Voluntary: Firm initiated