—#73598

Product

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.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051967
Affected lot / code info: 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, 00001004319WK8, 00001004330WK5, 00001004331WK3, 00001004332WK1, 00001004504WK5, 00001004505WK2, 00001004507WK8, 00001004508WK6, 00001004509WK4, 00001004510WK2, 00001004512WK8, 00001004513WK6, 00001004763WK7, 00001004764WK5, 00001004765WK2, 00001004766WK0, 00001004767WK8, 00001004768WK6, 00001004769WK4, 00001004770WK2, 00001004771WK0, 00001004772WK8, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005020WK1, 00001005021WK9, 00001005022WK7, 00001005023WK5, 00001005024WK3, 00001005025WK0, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005030WK0, 00001005031WK8, 00001005032WK6, 00001005033WK4, 00001005034WK2, 00001005035WK9, 00001005179WK5, 00001005180WK3, 00001005181WK1, 00001005182WK9, 00001005183WK7, 00001005184WK5, 00001005185WK2, 00001005186WK0, 00001005187WK8, 00001005188WK6, 00001005260WK3, 00001005319WK7, 00001005339WK5, 00001005669WK5, 00001005698WK4, 00001005699WK2, 00001005700WK8, 00001005701WK6, 00001005702WK4, 00001005705WK7, 00001005706WK5, 00001005707WK3, 00001005755WK2, 00001005757WK8, 00001005758WK6, 00001005759WK4, 00001005760WK2, 00001005761WK0, 00001005762WK8, 00001005763WK6, 00001005764WK4, 00001005841WK0, 00001005911WK1, 00001005912WK9, 00001005913WK7, 00001005914WK5, 00001005915WK2, 00001006015WK0, 00001006040WK8, 00001006041WK6, 00001006042WK4, 00001006043WK2, 00001006044WK0, 00001006177WK8, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006474WK9, 00001006475WK6, 00001006476WK4, 00001006477WK2, 00001006478WK0, 00001006631WK4, 00001006633WK0, 00001006634WK8, 00001006635WK5, 00001006636WK3, 00001006637WK1, 00001006638WK9, 00001006664WK5, 00001006665WK2, 00001006666WK0, 00001006667WK8, 00001006668WK6, 00001006822WK9, 00001006833WK6, 00001006834WK4, 00001006871WK6, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006876WK5, 00001006877WK3, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007161WK1, 00001007162WK9, 00001007163WK7, 00001007164WK5, 00001007165WK2, 00001007166WK0, 00001007167WK8, 00001007168WK6, 00001007169WK4, 00001007188WK4, 00001007189WK2, 00001007190WK0, 00001007191WK8, 00001007192WK6, 00001007403WK7, 00001007404WK5, 00001007405WK2, 00001007406WK0, 00001007407WK8, 00001007409WK4, 00001007476WK3, 00001007477WK1, 00001007478WK9, 00001007480WK5, 00001007497WK9, 00001007498WK7, 00001007499WK5, 00001007516WK6, 00001007517WK4, 00001007518WK2, 00001007525WK7, 00001007527WK3, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007533WK1, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007642WK0, 00001007643WK8, 00001007644WK6, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007649WK5, 00001007650WK3, 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, 00001007907WK7, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008312WK9, 00001008313WK7, 00001008314WK5, 00001008315WK2, 00001008316WK0, 00001008497WK8, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008682WK5, 00001008684WK1, 00001008685WK8, 00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8, 00001008691WK6, 00001008807WK8, 00001008808WK6, 00001008809WK4, 00001008810WK2, 00001008811WK0, 00001008812WK8, 00001008813WK6, 00001008814WK4, 00001008816WK9, 00001008835WK9, 00001008837WK5, 00001008838WK3, 00001008839WK1, 00001008840WK9, 00001008841WK7, 00001008842WK5, 00001008843WK3, 00001008995WK1, 00001009057WK9, 00001009058WK7, 00001009059WK5, 00001009060WK3, 00001009061WK1, 00001009062WK9, 00001009063WK7, 00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009140WK3, 00001009141WK1, 00001009142WK9, 00001009143WK7, 00001009144WK5, 00001009145WK2, 00001009146WK0, 00001009147WK8, 00001009213WK8, 00001009215WK3, 00001009216WK1, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009221WK1, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009268WK2, 00001009269WK0, 00001009270WK8, 00001009271WK6, 00001009273WK2, 00001009373WK0, 00001009374WK8, 00001009375WK5, 00001009376WK3, 00001009377WK1, 00001009378WK9, 00001009379WK7, 00001009380WK5, 00001009381WK3, 00001009382WK1, 00001009528WK9, 00001009529WK7, 00001009530WK5, 00001009532WK1, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0, 00001009592WK5, 00001009593WK3, 00001009601WK4, 00001009602WK2, 00001009603WK0, 00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009607WK1, 00001009609WK7, 00001009610WK5, 00001009707WK9, 00001009708WK7, 00001009709WK5, 00001009710WK3, 00001009712WK9, 00001009713WK7, 00001009714WK5, 00001009716WK0, 00001009816WK8, 00001009817WK6, 00001009818WK4, 00001009819WK2, 00001009821WK8, 00001009822WK6, 00001009823WK4, 00001009824WK2, 00001009873WK9, 00001009875WK4, 00001009876WK2, 00001009929WK9, 00001009930WK7, 00001009931WK5, 00001009932WK3, 00001009933WK1, 00001009934WK9, 00001009938WK0, 00001009976WK0, 00001009977WK8, 00001009979WK4, 00001009981WK0, 00001009983WK6, 00001009984WK4, 00001009985WK1, 00001010085WK7, 00001010086WK5, 00001010098WK0, 00001010099WK8, 00001010100WK4, 00001010101WK2, 00001010102WK0, 00001010103WK8, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010158WK2, 00001010159WK0, 00001010160WK8, 00001010161WK6, 00001010162WK4, 00001010167WK3, 00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010239WK0, 00001010240WK8, 00001010241WK6, 00001010242WK4, 00001010243WK2, 00001010291WK1, 00001010292WK9, 00001010293WK7, 00001010294WK5, 00001010295WK2, 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, 00001010907WK2, 00001010908WK0, 00001010909WK8, 00001010911WK4, 00001010960WK1, 00001010962WK7, 00001010963WK5, 00001010964WK3, 00001010967WK6, 00001011022WK9, 00001011079WK9, 00001011080WK7, 00001011081WK5, 00001011082WK3, 00001011083WK1, 00001011084WK9, 00001011085WK6, 00001011086WK4, 00001011087WK2, 00001011088WK0, 00001011089WK8, 00001011090WK6, 00001011091WK4, 00001011092WK2, 00001011210WK0, 00001011211WK8, 00001011212WK6, 00001011213WK4, 00001011214WK2, 00001011215WK9, 00001011216WK7, 00001011218WK3, 00001011219WK1, 00001011283WK7, 00001011284WK5, 00001011285WK2, 00001011286WK0, 00001011287WK8, 00001011288WK6, 00001011289WK4, 00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011329WK8, 00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011384WK3, 00001011385WK0, 00001011386WK8, 00001011387WK6, 00001011388WK4, 00001011389WK2, 00001011448WK6, 00001011449WK4, 00001011450WK2, 00001011452WK8, 00001011454WK4, 00001011455WK1, 00001011485WK8, 00001011486WK6, 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.

Why it was recalled

Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Field Engineer will visit each site to implement the correct label. Contact GE Healthcare at 1-262-544-3894 for assistance.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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,

Timeline

Recall initiated: 2008-01-02
Posted by FDA: 2008-09-25
Terminated: 2011-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73598. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.