GE Healthcare GE Healthcare Definium 8000 Digital Radiographic System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Definium 8000 Digital Radiographic System.
Brand
GE Healthcare
Lot Codes / Batch Numbers
0000000002772E, 00000001191M36, 00000001561M30, 00000001895M32, 00000002041M32, 00000002051M31, 00000002052M39, 00000002065M31, 00000002364M38, 00000002439M38, 00000002441M34, 00000002650M30, 00000002767EN2, 00000002771M34, 00000002968M36, 00000003468M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004105M33, 00000004199M36, 00000004442M30, 00000096383DP5, 00000096401DP5, 00000097412DP1, 00000097656DP3, 00000097918DP7, 00000114134VE0, 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, 00000TA42274-8, 00000TA42869-6, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004163WK0, 00001004319WK8, 00001004331WK3, 00001004508WK6, 00001004509WK4, 00001004512WK8, 00001004763WK7, 00001004767WK8, 00001004769WK4, 00001004771WK0, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005021WK9, 00001005023WK5, 00001005025WK0, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005032WK6, 00001005033WK4, 00001005034WK2, 00001005179WK5, 00001005180WK3, 00001005183WK7, 00001005184WK5, 00001005185WK2, 00001005186WK0, 00001005187WK8, 00001005319WK7, 00001005669WK5, 00001005698WK4, 00001005699WK2, 00001005701WK6, 00001005702WK4, 00001005705WK7, 00001005706WK5, 00001005707WK3, 00001005755WK2, 00001005757WK8, 00001005759WK4, 00001005761WK0, 00001005762WK8, 00001005763WK6, 00001005764WK4, 00001005841WK0, 00001005911WK1, 00001005912WK9, 00001005913WK7, 00001005915WK2, 00001006015WK0, 00001006040WK8, 00001006041WK6, 00001006043WK2, 00001006044WK0, 00001006177WK8, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006475WK6, 00001006476WK4, 00001006477WK2, 00001006478WK0, 00001006631WK4, 00001006633WK0, 00001006634WK8, 00001006664WK5, 00001006665WK2, 00001006666WK0, 00001006667WK8, 00001006822WK9, 00001006833WK6, 00001006834WK4, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006876WK5, 00001006877WK3, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007162WK9, 00001007163WK7, 00001007164WK5, 00001007165WK2, 00001007167WK8, 00001007168WK6, 00001007169WK4, 00001007188WK4, 00001007189WK2, 00001007190WK0, 00001007191WK8, 00001007192WK6, 00001007405WK2, 00001007406WK0, 00001007407WK8, 00001007409WK4, 00001007476WK3, 00001007477WK1, 00001007478WK9, 00001007497WK9, 00001007498WK7, 00001007499WK5, 00001007516WK6, 00001007517WK4, 00001007518WK2, 00001007525WK7, 00001007527WK3, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007533WK1, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007642WK0, 00001007643WK8, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007649WK5, 00001007651WK1, 00001007713WK9, 00001007715WK4, 00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007721WK2, 00001007776WK6, 00001007777WK4, 00001007778WK2, 00001007779WK0, 00001007779WK0, 00001007780WK8, 00001007781WK6, 00001007782WK4, 00001007783WK2, 00001007784WK0, 00001007785WK7, 00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008313WK7, 00001008315WK2, 00001008316WK0, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008682WK5, 00001008685WK8, 00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8, 00001008691WK6, 00001008807WK8, 00001008808WK6, 00001008809WK4, 00001008810WK2, 00001008811WK0, 00001008812WK8, 00001008814WK4, 00001008816WK9, 00001008835WK9, 00001008837WK5, 00001008838WK3, 00001008839WK1, 00001008840WK9, 00001008841WK7, 00001008842WK5, 00001008843WK3, 00001008995WK1, 00001009057WK9, 00001009058WK7, 00001009059WK5, 00001009060WK3, 00001009061WK1.00001009062WK9, 00001009063WK7, 00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009141WK1, 00001009142WK9, 00001009144WK5, 00001009146WK0, 00001009147WK8, 00001009213WK8, 00001009215WK3, 00001009216WK1, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009221WK1, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009268WK2, 00001009269WK0, 00001009270WK8, 00001009271WK6, 00001009273WK2, 00001009373WK0, 00001009374WK8, 00001009376WK3, 00001009377WK1, 00001009378WK9, 00001009381WK3, 00001009528WK9, 00001009529WK7, 00001009530WK5, 00001009532WK1, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0, 00001009592WK5, 00001009593WK3, 00001009601WK4, 00001009602WK2, 00001009603WK0, 00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009607WK1, 00001009609WK7, 00001009610WK5, 00001009707WK9, 00001009708WK7, 00001009710WK3, 00001009712WK9, 00001009713WK7, 00001009714WK5, 00001009716WK0, 00001009816WK8, 00001009817WK6, 00001009819WK2, 00001009821WK8, 00001009822WK6, 00001009823WK4, 00001009824WK2, 00001009873WK9, 00001009875WK4, 00001009876WK2, 00001009929WK9, 00001009930WK7, 00001009931WK5, 00001009933WK1, 00001009938WK0, 00001009977WK8, 00001009979WK4, 00001009981WK0, 00001009983WK6, 00001009984WK4, 00001009985WK1, 00001010085WK7, 00001010086WK5, 00001010098WK0, 00001010100WK4, 00001010101WK2, 00001010102WK0, 00001010103WK8, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010158WK2, 00001010159WK0, 00001010160WK8, 00001010162WK4, 00001010167WK3, 00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010239WK0, 00001010240WK8, 00001010241WK6, 00001010242WK4, 00001010243WK2, 00001010291WK1, 00001010293WK7, 00001010296WK0, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2, 00001010357WK0, 00001010432WK1, 00001010433WK9, 00001010489WK1, 00001010490WK9, 00001010491WK7, 00001010493WK3, 00001010521WK1, 00001010523WK7, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010529WK4, 00001010530WK2, 00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010628WK4, 00001010630WK0, 00001010631WK8, 00001010632WK6, 00001010633WK4, 00001010693WK8, 00001010694WK6, 00001010696WK1, 00001010697WK9, 00001010698WK7, 00001010721WK7, 00001010723WK3, 00001010786WK0, 00001010804WK1, 00001010805WK8, 00001010806WK6, 00001010807WK4, 00001010808WK2, 00001010902WK3, 00001010904WK9, 00001010905WK6, 00001010911WK4, 00001010960WK1, 00001010962WK7, 00001010967WK6, 00001011022WK9, 00001011079WK9, 00001011080WK7, 00001011081WK5, 00001011082WK3, 00001011085WK6, 00001011086WK4, 00001011087WK2, 00001011088WK0, 00001011090WK6, 00001011091WK4, 00001011210WK0, 00001011211WK8, 00001011212WK6, 00001011213WK4, 00001011214WK2, 00001011216WK7, 00001011218WK3, 00001011283WK7, 00001011284WK5, 00001011286WK0, 00001011287WK8, 00001011288WK6, 00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011385WK0, 00001011386WK8, 00001011387WK6, 00001011389WK2, 00001011449WK4, 00001011450WK2, 00001011700WK0, 00001011703WK4, 00001011712WK5, 00001012286WK9, 00001012453WK5, 00001013134WK0, 00001014310WK5, 00001014936WK7, 00001016147WK9.
Products Sold
0000000002772E, 00000001191M36, 00000001561M30, 00000001895M32, 00000002041M32, 00000002051M31, 00000002052M39, 00000002065M31, 00000002364M38, 00000002439M38, 00000002441M34, 00000002650M30, 00000002767EN2, 00000002771M34, 00000002968M36, 00000003468M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004105M33, 00000004199M36, 00000004442M30, 00000096383DP5, 00000096401DP5, 00000097412DP1, 00000097656DP3, 00000097918DP7, 00000114134VE0, 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, 00000TA42274-8, 00000TA42869-6, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004163WK0, 00001004319WK8, 00001004331WK3, 00001004508WK6, 00001004509WK4, 00001004512WK8, 00001004763WK7, 00001004767WK8, 00001004769WK4, 00001004771WK0, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005021WK9, 00001005023WK5, 00001005025WK0, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005032WK6, 00001005033WK4, 00001005034WK2, 00001005179WK5, 00001005180WK3, 00001005183WK7, 00001005184WK5, 00001005185WK2, 00001005186WK0, 00001005187WK8, 00001005319WK7, 00001005669WK5, 00001005698WK4, 00001005699WK2, 00001005701WK6, 00001005702WK4, 00001005705WK7, 00001005706WK5, 00001005707WK3, 00001005755WK2, 00001005757WK8, 00001005759WK4, 00001005761WK0, 00001005762WK8, 00001005763WK6, 00001005764WK4, 00001005841WK0, 00001005911WK1, 00001005912WK9, 00001005913WK7, 00001005915WK2, 00001006015WK0, 00001006040WK8, 00001006041WK6, 00001006043WK2, 00001006044WK0, 00001006177WK8, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006475WK6, 00001006476WK4, 00001006477WK2, 00001006478WK0, 00001006631WK4, 00001006633WK0, 00001006634WK8, 00001006664WK5, 00001006665WK2, 00001006666WK0, 00001006667WK8, 00001006822WK9, 00001006833WK6, 00001006834WK4, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006876WK5, 00001006877WK3, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007162WK9, 00001007163WK7, 00001007164WK5, 00001007165WK2, 00001007167WK8, 00001007168WK6, 00001007169WK4, 00001007188WK4, 00001007189WK2, 00001007190WK0, 00001007191WK8, 00001007192WK6, 00001007405WK2, 00001007406WK0, 00001007407WK8, 00001007409WK4, 00001007476WK3, 00001007477WK1, 00001007478WK9, 00001007497WK9, 00001007498WK7, 00001007499WK5, 00001007516WK6, 00001007517WK4, 00001007518WK2, 00001007525WK7, 00001007527WK3, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007533WK1, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007642WK0, 00001007643WK8, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007649WK5, 00001007651WK1, 00001007713WK9, 00001007715WK4, 00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007721WK2, 00001007776WK6, 00001007777WK4, 00001007778WK2, 00001007779WK0, 00001007779WK0, 00001007780WK8, 00001007781WK6, 00001007782WK4, 00001007783WK2, 00001007784WK0, 00001007785WK7, 00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008313WK7, 00001008315WK2, 00001008316WK0, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008682WK5, 00001008685WK8, 00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8, 00001008691WK6, 00001008807WK8, 00001008808WK6, 00001008809WK4, 00001008810WK2, 00001008811WK0, 00001008812WK8, 00001008814WK4, 00001008816WK9, 00001008835WK9, 00001008837WK5, 00001008838WK3, 00001008839WK1, 00001008840WK9, 00001008841WK7, 00001008842WK5, 00001008843WK3, 00001008995WK1, 00001009057WK9, 00001009058WK7, 00001009059WK5, 00001009060WK3, 00001009061WK1.00001009062WK9, 00001009063WK7, 00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009141WK1, 00001009142WK9, 00001009144WK5, 00001009146WK0, 00001009147WK8, 00001009213WK8, 00001009215WK3, 00001009216WK1, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009221WK1, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009268WK2, 00001009269WK0, 00001009270WK8, 00001009271WK6, 00001009273WK2, 00001009373WK0, 00001009374WK8, 00001009376WK3, 00001009377WK1, 00001009378WK9, 00001009381WK3, 00001009528WK9, 00001009529WK7, 00001009530WK5, 00001009532WK1, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0, 00001009592WK5, 00001009593WK3, 00001009601WK4, 00001009602WK2, 00001009603WK0, 00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009607WK1, 00001009609WK7, 00001009610WK5, 00001009707WK9, 00001009708WK7, 00001009710WK3, 00001009712WK9, 00001009713WK7, 00001009714WK5, 00001009716WK0, 00001009816WK8, 00001009817WK6, 00001009819WK2, 00001009821WK8, 00001009822WK6, 00001009823WK4, 00001009824WK2, 00001009873WK9, 00001009875WK4, 00001009876WK2, 00001009929WK9, 00001009930WK7, 00001009931WK5, 00001009933WK1, 00001009938WK0, 00001009977WK8, 00001009979WK4, 00001009981WK0, 00001009983WK6, 00001009984WK4, 00001009985WK1, 00001010085WK7, 00001010086WK5, 00001010098WK0, 00001010100WK4, 00001010101WK2, 00001010102WK0, 00001010103WK8, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010158WK2, 00001010159WK0, 00001010160WK8, 00001010162WK4, 00001010167WK3, 00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010239WK0, 00001010240WK8, 00001010241WK6, 00001010242WK4, 00001010243WK2, 00001010291WK1, 00001010293WK7, 00001010296WK0, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2, 00001010357WK0, 00001010432WK1, 00001010433WK9, 00001010489WK1, 00001010490WK9, 00001010491WK7, 00001010493WK3, 00001010521WK1, 00001010523WK7, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010529WK4, 00001010530WK2, 00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010628WK4, 00001010630WK0, 00001010631WK8, 00001010632WK6, 00001010633WK4, 00001010693WK8, 00001010694WK6, 00001010696WK1, 00001010697WK9, 00001010698WK7, 00001010721WK7, 00001010723WK3, 00001010786WK0, 00001010804WK1, 00001010805WK8, 00001010806WK6, 00001010807WK4, 00001010808WK2, 00001010902WK3, 00001010904WK9, 00001010905WK6, 00001010911WK4, 00001010960WK1, 00001010962WK7, 00001010967WK6, 00001011022WK9, 00001011079WK9, 00001011080WK7, 00001011081WK5, 00001011082WK3, 00001011085WK6, 00001011086WK4, 00001011087WK2, 00001011088WK0, 00001011090WK6, 00001011091WK4, 00001011210WK0, 00001011211WK8, 00001011212WK6, 00001011213WK4, 00001011214WK2, 00001011216WK7, 00001011218WK3, 00001011283WK7, 00001011284WK5, 00001011286WK0, 00001011287WK8, 00001011288WK6, 00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011385WK0, 00001011386WK8, 00001011387WK6, 00001011389WK2, 00001011449WK4, 00001011450WK2, 00001011700WK0, 00001011703WK4, 00001011712WK5, 00001012286WK9, 00001012453WK5, 00001013134WK0, 00001014310WK5, 00001014936WK7, 00001016147WK9.
GE Healthcare is recalling GE Healthcare Definium 8000 Digital Radiographic System. due to Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC con. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator software errors may cause light X-ray Images with reported mAs readings higher than was actually exposed to the patient using the overhead X-ray tube. The mAs rea
Recommended Action
Per FDA guidance
GE sent a Product Safety Notification dated March 7, 2008 to all customers. The letter described the safety issue, affected product, and stated that a GE Healthcare Field Engineer will schedule a field visit to install software updates.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026