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U.S. Department of Health and Human Services

Class 2 Device Recall GE Definium 8000

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  Class 2 Device Recall GE Definium 8000 see related information
Date Initiated by Firm March 07, 2008
Date Posted September 25, 2008
Recall Status1 Terminated 3 on December 11, 2011
Recall Number Z-1822-2008
Recall Event ID 49504
510(K)Number K051967  
Product Classification Digital Radiographic System - Product Code KPR
Product GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.
Code Information 00000002047M39, 00000005487M34, 00000096986DP%, 00000100740WK6, 00000TA41882-7, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA42274-8, 00000TA42869-6, 00001004330WK5, 00001004332WK1, 00001004504WK5, 00001004505WK2, 00001004510WK2, 00001004513WK6, 00001004764WK5, 00001004765WK2, 00001004766WK0, 00001004768WK6, 00001004770WK2, 00001004772WK8, 00001005020WK1, 00001005022WK7, 00001005024WK3, 00001005030WK0, 00001005031WK8, 00001005035WK9, 00001005181WK1, 00001005182WK9, 00001005188WK6, 00001005260WK3, 00001005339WK5, 00001005758WK6, 00001005914WK5, 00001006042WK4, 00001006474WK9, 00001006635WK5, 00001006637WK1, 00001006638WK9, 00001006668WK6, 00001006871WK6, 00001007161WK1, 00001007166WK0, 00001007403WK7, 00001007404WK5, 00001007480WK5, 00001007536WK4, 00001007644WK6, 00001007650WK3, 00001007907WK7, 00001008312WK9, 00001008314WK5, 00001008497WK8, 00001008684WK1, 00001008807WK8, 00001008813WK6, 00001009140WK3, 00001009143WK7, 00001009145WK2, 00001009216WK1, 00001009268WK2, 00001009375WK5, 00001009380WK5, 00001009382WK1, 00001009709WK5, 00001009818WK4, 00001009875WK4, 00001009934WK9, 00001009976WK0, 00001010085WK7, 00001010099WK8, 00001010161WK6, 00001010239WK0, 00001010294WK5, 00001010295WK2, 00001010297WK8, 00001010431WK3, 00001010488WK3, 00001010524WK5, 00001010628WK4, 00001010629WK2, 00001010687WK0, 00001010693WK8, 00001010695WK3, 00001010906WK4, 00001010907WK2, 00001010964WK3, 00001011084WK9, 00001011085WK6, 00001011092WK2, 00001011215WK9, 00001011285WK2, 00001011289WK4, 00001011386WK8, 00001011455WK1, 00001011488WK2, 00001011490WK8, 00001011647WK3, 00001011654WK9, 00001011700WK0, 00001011712WK5, 00001011822WK2, 00001011825WK5, 00001011827WK1, 00001011828WK9, 00001011829WK7, 00001011832WK1, 00001012012WK9, 00001012119WK2, 00001012286WK9, 00001012449WK3, 00001012450WK1, 00001012453WK5, 00001012923WK7, 00001013064WK9, 00001013067WK2, 00001013100WK1, 00001013101WK9, 00001013134WK0, 00001013136WK5, 00001013223WK1, 00001013334WK6, 00001013336WK1, 00001013622WK4, 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		 Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the Wallstand receptor will be offset by 17mm. This prevents the visualization of anatomy WITHIN a distance of 17mm from the wallstand patient barrier (receptor cover).
FDA Determined
Cause 2		 Software design
Action GE sent a Product Safety Notification, dated March 7, 2008, to all customers. The letter described the safety issue, products affected, and stated that a GE Healthcare Field Engineer will schedule a visit to each facility to install a software modification.
Quantity in Commerce 127
Distribution Worldwide distribution: USA, Australia, Belgium, Canada, China, Finland, France, Germany, Great Britain, Italy, Netherlands, Spain, and Sweden.
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 and Original Applicant = GE HEALTHCARE
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