Recall Z-2257-2013— GE Healthcare, LLC

Name: FDA recall Z-2257-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-20

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-09-20, terminated 2016-07-07. It names one FDA 510(k) clearance: K033400. Product: GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. 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 recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Terminated: 2016-07-07
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, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. 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 recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.

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