Device Recall GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM

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Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including states: AL, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PR, RI, SC, SD, TN, TX, and WV; and countries including: URUGUAY, TURKEY, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, PUERTO RICO, PORTUGAL, POLAND, PARAGUAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LEBANON, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, EGYPT, COLOMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BELARUS, BAHRAIN, AUSTRALIA, ANGOLA, ALGERIA. TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, PHILIPPINES, PARAGUAY, OMAN, NEW ZEALAND, MOROCCO, KUWAIT, KAZAKHSTAN, ISLAMIC REPUBLIC OF IRAN, ARGENTINA.

BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. || The GE BrightSpeed Delight Series 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, for patients of all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast.