PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 21, 2013 Initiated: April 5, 2011 #Z-1940-2013

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

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
244
Distribution
Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT, FL, GA, HI, IL, IN, IA, KY,ME, MD,MA, MI,MN, MS, NV, NH, NJ, NY, NC, PA, TN, TX, VA, WA,WV, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANDA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, NEW ZEALAND, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUKEY, and UNITED KINGDOM.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 244.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1940-2013.

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