Recall Z-0125-2013— GE Healthcare, LLC

Name: FDA recall Z-0125-2013
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 2012-12-11. It names one FDA 510(k) clearance: K033400. Product: GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.. Reason: GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-05-24
Terminated: 2012-12-11
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K033400 — SENO ADVANTAGEGe Medical Systems W-400·cleared 2003-12-04

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

GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.

Reason for recall

GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.

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