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U.S. Department of Health and Human Services

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BRAND NAMESIGNA MR SYSTEM
MANUFACTURER
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE WI 53201
ACCESS NUMBERM183091
PRODUCT CODELNH
PANELRADIOLOGICAL
REPORT TYPEMALFUNCTION
DATE FDA RECEIVED01/03/1990
DEVICE MODEL NUMBER46-243180G1
EVENT DESCRIPTION TYPEFINAL
EVENT DESCRIPTION
IT WAS REPORTED TO CO THAT SURGERY WAS PERFORMED ON A PT BASED ON AN ARTIFACT ON A MR IMAGE. THE HOSPITAL HAS REFUSED TO GIVE CO ANY FURTHER INFO, SUCH AS INCIDENT DATE & PT CONDITION.
CLOSEOUT TEXT
THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE CAUSE ASSOCIATED WITH THIS TYPE OF EVENT IS USUALLY ATTRIBUTED TO THE DEVICE. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.
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