Recall Z-1245-2014— GE Healthcare, LLC

Name: FDA recall Z-1245-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-14

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-02-14, terminated 2015-04-29. It names one FDA 510(k) clearance: K093581. Product: GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.. Reason: GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO).

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-02-14
Terminated: 2015-04-29
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K093581 — DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMSGe Medical Systems, LLC·cleared 2011-04-19

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 Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO)

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