Recall Z-0754-2013— GE Healthcare, LLC

Name: FDA recall Z-0754-2013
Creator: U.S. Food and Drug Administration
Published: 2012-05-24

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-05-24, terminated 2014-01-16. It names one FDA 510(k) clearance: K052345. Product: AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.. Reason: It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-05-24
Terminated: 2014-01-16
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K052345 — ADVANTAGE SIM MDGE Healthcare·cleared 2005-09-14

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

AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.

Reason for recall

It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.

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