Recall Z-1088-2015— Elekta, Inc.

Name: FDA recall Z-1088-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-07

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2015-01-07, terminated 2016-04-14. It names one FDA 510(k) clearance: K051932. Product: Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.. Reason: Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-07
Terminated: 2016-04-14
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

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

Reason for recall

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

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