Recall of Device Recall GE Definium 8000

serial numbers: 0000000002772E, 00000001191M36, 00000001561M30, 00000001895M32, 00000002041M32, 00000002047M39, 00000002051M31, 00000002052M39, 00000002065M31, 00000002364M38, 00000002439M38, 00000002441M34, 00000002650M30, 00000002767EN2, 00000002771M34, 00000002965M32, 00000002968M36, 00000003468M36, 00000003505M35, 00000003506M33, 00000003806M37, 00000004101M32, 00000004105M33, 00000004199M36, 00000004442M30, 00000004547M36, 00000005052M36, 00000005487M34, 00000096383DP5, 00000096401DP5, 00000096986DP%, 00000097412DP1, 00000097656DP3, 00000097918DP7, 00000100740WK6, 00000114134VE0, 00000114148VE0, 00000114297VE5, 00000114452VE6, 00000TA41711-6, 00000TA41732-3, 00000TA41827-4, 00000TA41867-8, 00000TA41882-7, 00000TA41896¿4, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA41995-7, 00000TA42004¿5, 00000TA42007-4, 00000TA42020-3, 00000TA42025¿4, 00000TA42184-1, 00000TA42274-8, 00000TA42869-6, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004163WK0, 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00001010296WK0, 00001010297WK8, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2, 00001010357WK0, 00001010431WK3, 00001010432WK1, 00001010433WK9, 00001010488WK3, 00001010489WK1, 00001010490WK9, 00001010491WK7, 00001010493WK3, 00001010521WK1, 00001010523WK7, 00001010524WK5, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010529WK4, 00001010530WK2, 00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010628WK4, 00001010629WK2, 00001010630WK0, 00001010631WK8, 00001010632WK6, 00001010633WK4, 00001010687WK0, 00001010693WK8, 00001010694WK6, 00001010695WK3, 00001010696WK1, 00001010697WK9, 00001010698WK7, 00001010720WK9, 00001010721WK7, 00001010723WK3, 00001010782WK9, 00001010785WK2, 00001010786WK0, 00001010804WK1, 00001010805WK8, 00001010806WK6, 00001010807WK4, 00001010808WK2, 00001010810WK8, 00001010811WK6, 00001010902WK3, 00001010903WK1, 00001010904WK9, 00001010905WK6, 00001010906WK4, 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00001011487WK4, 00001011488WK2, 00001011489WK0, 00001011490WK8, 00001011491WK6, 00001011492WK4, 00001011494WK0, 00001011495WK7, 00001011496WK5, 00001011630WK9, 00001011631WK7, 00001011632WK5, 00001011633WK3, 00001011634WK1, 00001011635WK8, 00001011643WK2, 00001011645WK7, 00001011647WK3, 00001011648WK1, 00001011652WK3, 00001011653WK1, 00001011654WK9, 00001011697WK8, 00001011698WK6, 00001011699WK4, 00001011700WK0, 00001011702WK6, 00001011703WK4, 00001011711WK7, 00001011712WK5, 00001011714WK1, 00001011715WK8, 00001011716WK6, 00001011821WK4, 00001011822WK2, 00001011824WK8, 00001011825WK5, 00001011826WK3, 00001011827WK1, 00001011828WK9, 00001011829WK7, 00001011830WK5, 00001011831WK3, 00001011832WK1, 00001011926WK1, 00001011927WK9, 00001011928WK7, 00001011962WK6, 00001012011WK1, 00001012012WK9, 00001012013WK7, 00001012014WK5, 00001012015WK2, 00001012117WK6, 00001012118WK4, 00001012119WK2, 00001012120WK0, 00001012121WK8, 00001012122WK6, 00001012164WK8, 00001012165WK5, 00001012173WK9, 00001012278WK6, 00001012280WK2, 00001012284WK4, 00001012286WK9, 00001012299WK2, 00001012428WK7, 00001012429WK5, 00001012430WK3, 00001012431WK1, 00001012449WK3, 00001012450WK1, 00001012451WK9, 00001012452WK7, 00001012453WK5, 00001012593WK8, 00001012594WK6, 00001012622WK5, 00001012623WK3, 00001012923WK7, 00001012925WK2, 00001012927WK8, 00001012928WK6, 00001012929WK4, 00001012930WK2, 00001012931WK0, 00001013005WK2, 00001013025WK0, 00001013064WK9, 00001013067WK2, 00001013100WK1, 00001013101WK9, 00001013134WK0, 00001013136WK5, 00001013143WK1, 00001013145WK6, 00001013222WK3, 00001013223WK1, 00001013224WK9, 00001013225WK6, 00001013304WK9, 00001013305WK6, 00001013334WK6, 00001013335WK3, 00001013336WK1, 00001013337WK9, 00001013622WK4, 00001014310WK5, 00001014936WK7, and 00001016147WK9.

Radiology Devices

2

No

AL, CA, CO, CT, DE, FL, GA, IA,, IL,, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI,WV and Washington D.C. OUS to include: Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Malta, Martinique (French), Netherlands, Norway, Palestine, Portugal, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and Yugoslavia,

GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A. || The intended use of this product is to generate tomographic images of human anatomy.