Recall Z-1940-2013— GE Healthcare, LLC

Name: FDA recall Z-1940-2013
Creator: U.S. Food and Drug Administration
Published: 2011-04-05

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2011-04-05, terminated 2014-08-11. It names one FDA 510(k) clearance: K081105. Product: GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages.. Reason: GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does no.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2011-04-05
Terminated: 2014-08-11
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K081105 — GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)GE Healthcare·cleared 2008-05-09

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 LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages.

Reason for recall

GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does no

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