Recall Z-1061-2014— Elekta, Inc.

Name: FDA recall Z-1061-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-25

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-11-25, terminated 2016-12-14. It names one FDA 510(k) clearance: K051932. Product: Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.. Reason: Potential collision risk when using XVI and external beam shaping devices..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Terminated: 2016-12-14
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

Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Reason for recall

Potential collision risk when using XVI and external beam shaping devices.

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