Recall Z-0234-2018— Elekta Inc

Name: FDA recall Z-0234-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-01

Class II · Terminated

Class II FDA medical device recall by Elekta Inc, initiated 2017-09-01, terminated 2019-11-05. It names one FDA 510(k) clearance: K080601. Product: Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.. Reason: Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning..

Recalling firm: Elekta Inc
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Terminated: 2019-11-05
Firm location: Maryland Heights, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K080601 — ERGO++ VERSION 1.73D Line Medical Systems S.R.L.·cleared 2008-06-06

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 ERGO++ Product Usage: ERGO is often used for stereotactic treatments.

Reason for recall

Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.

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