GE Healthcare Definium 8000 Digital Radiographic System…

Date posted by the FDA

Sept. 25, 2008

Status

Terminated

Filed by

GE Healthcare

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.

Reason

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

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,

Quantity

668 (419 US / 249 OUS)

Codes and lots

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…

Recall started

Jan. 2, 2008

Device type

System, X-Ray, Stationary

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

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

Recall number

Z-1883-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1883-2008. The agency record governs; check it and the company before acting.