Recall Z-1137-2013— GE Healthcare, LLC

Name: FDA recall Z-1137-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-28

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-06-28, terminated 2014-02-04. It names one FDA 510(k) clearance: K081985. Product: GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.. Reason: GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-06-28
Terminated: 2014-02-04
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K081985 — AW SERVERGe Medical Systems, LLC·cleared 2008-09-25

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, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe

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