Recall Z-1511-2014— GE Healthcare, LLC

Name: FDA recall Z-1511-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-07

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-04-07, terminated 2014-05-29. It names one FDA 510(k) clearance: K121762. Product: GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.. Reason: GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-04-07
Terminated: 2014-05-29
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K121762 — CARDIAC VXGe Medical Systems, LLC·cleared 2013-01-18

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, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.

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