Recall Z-2405-2012— Elekta, Inc.

Name: FDA recall Z-2405-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-06

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2012-08-06, terminated 2014-10-08. It names one FDA 510(k) clearance: K051932. Product: Precise Digital Accelerator Delivery of radiation to defined target volumes. Reason: There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-06
Terminated: 2014-10-08
Firm location: Norcross, 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

Precise Digital Accelerator Delivery of radiation to defined target volumes

Reason for recall

There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

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