Recall Z-0152-2015— Elekta, Inc.

Name: FDA recall Z-0152-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-06

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2014-10-06, terminated 2021-09-15. It names one FDA 510(k) clearance: K120811. Product: Laksell Gamma Knife Perfexion. Reason: Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Terminated: 2021-09-15
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K120811 — LEKSELL GAMMA KNIFE PERFEXIONElekta Instrument AB·cleared 2012-05-24

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

Laksell Gamma Knife Perfexion

Reason for recall

Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.

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