Recall Z-1065-2014— Elekta, Inc.

Name: FDA recall Z-1065-2014
Creator: U.S. Food and Drug Administration
Published: 2013-05-28

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-05-28, terminated 2021-09-15. It names one FDA 510(k) clearance: K051932. Product: All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes. Reason: Customers are resetting the default values outside recommended factory settings..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Terminated: 2021-09-15
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K051932 — ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5Elekta, Inc.·cleared 2005-08-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Customers are resetting the default values outside recommended factory settings.

Data sourced from openFDA. This site is unofficial and independent of the FDA.