—#73650

Product

GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K051967
Affected lot / code info: 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

Why it was recalled

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).

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA, Australia, Belgium, Canada, China, Finland, France, Germany, Great Britain, Italy, Netherlands, Spain, and Sweden.

Timeline

Recall initiated: 2008-03-07
Posted by FDA: 2008-09-25
Terminated: 2011-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73650. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.