FDA-Device2015-03-18Class II
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
GE Healthcare
Hazard
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
Sold states
Worldwide Distribution-US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI,and WV, and the countries of ARGENTINA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, IRELAND, ITALY, JAPAN, NEW ZEALAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, and UNITED KINGDOM.
Affected count
192 (131 US, 61 OUS).
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2015Don't want to check this manually?
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