Recall Z-1561-2016— Elekta, Inc.

Name: FDA recall Z-1561-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-19

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2016-04-19, terminated 2021-07-16. It names 2 FDA 510(k) clearances: K151159, K151561. Product: Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.. Reason: The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-19
Terminated: 2021-07-16
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

2 on FDA's record

K151159 — Leksell Gamma Knife PerfexionElekta Instrument AB·cleared 2015-10-29
K151561 — Leksell Gamma Knife IconElekta Instrument AB·cleared 2015-08-04

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

Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

Reason for recall

The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.

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