FDA Devices Moderate Class II Terminated

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

Reported: March 12, 2014 Initiated: May 28, 2013 #Z-1065-2014

Product Description

Reason for Recall

Customers are resetting the default values outside recommended factory settings.

Details

Recalling Firm: Elekta, Inc.
Units Affected: 472 units
Distribution: USA Nationwide Distribution in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC and including Puerto Rico.
Location: Atlanta, GA

Frequently Asked Questions

What product was recalled? ▼

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes. Recalled by Elekta, Inc.. Units affected: 472 units.

Why was this product recalled? ▼

Customers are resetting the default values outside recommended factory settings.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 12, 2014. Severity: Moderate. Recall number: Z-1065-2014.