Recall Z-0931-2013— Elekta, Inc.

Name: FDA recall Z-0931-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-19

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2012-12-19, terminated 2021-07-14. It names one FDA 510(k) clearance: K051932. Product: Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.. Reason: The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-12-19
Terminated: 2021-07-14
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

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

Reason for recall

The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.

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