Recall Z-0095-2013— GE Healthcare, LLC

Name: FDA recall Z-0095-2013
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 2013-03-26. It names one FDA 510(k) clearance: K033400. Product: GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is 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. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.. Reason: GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-05-24
Terminated: 2013-03-26
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 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is 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. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

Reason for recall

GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv

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