Recall Z-1238-2015— Elekta, Inc.

Name: FDA recall Z-1238-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-29

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2015-01-29, terminated 2021-11-05. It names one FDA 510(k) clearance: K983678. Product: Elekta Precise Treatment Table. Reason: It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-29
Terminated: 2021-11-05
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K983678 — ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEElekta Instruments, Inc.·cleared 1999-01-15

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

Elekta Precise Treatment Table

Reason for recall

It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.

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