Recall Z-1072-2013— Elekta, Inc.

Name: FDA recall Z-1072-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-14

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-03-14, terminated 2015-03-17. It names one FDA 510(k) clearance: K983678. Product: Precise Treatment Table. To be used as part of radiation therapy treatment process.. Reason: The Column rotation can accidentally be moved to a different position which in the locked position..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-14
Terminated: 2015-03-17
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

Precise Treatment Table. To be used as part of radiation therapy treatment process.

Reason for recall

The Column rotation can accidentally be moved to a different position which in the locked position.

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