Class 2 Device Recall GE Definium 8000

• Date Initiated by Firm: March 07, 2008
• Date Posted: September 25, 2008
• Recall Status: Terminated on January 07, 2012
• Recall Number: Z-1882-2008
• Recall Event ID: 49503
• 510(K)Number: K051967
• Product Classification: Digital Radiographic System - Product Code KPR
• Product: GE Healthcare Definium 8000 Digital Radiographic System.
• Code Information: 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, 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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.
• Recalling Firm/ Manufacturer: GE Healthcare; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 454 (277 US / 177 OUS)
• Distribution: Worldwide Distribution: USA, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Martinique (French), Netherlands, Norway, Palestine, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, and Yugoslavia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPR