GE Healthcare: GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.

Recall number

Z-1476-2008

Recalling firm

GE Healthcare

Product

GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.

Status

Terminated

Initiated

2007-08-13

Posted

2008-09-18

Terminated

2010-10-07

Reason

Necessary certification labels are missing from the x-ray contol.

Root cause

Radiation Control for Health and Safety Act

Action

A field Engineer from GE will visit the customer site to apply label to the X-ray control.

Quantity

448

Distribution

Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.

Lot, serial or model codes

serial numbers: 0000000002772E, 00000001191M36, 00000002065M31, 00000002650M30, 00000002753EN2, 00000002767EN2, 00000002968M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004547M36, 00000005487M34, 00000096383DP5, 00000097656DP3, 00000100740WK6, 00000114297VE5, 00000989905WK5, 00000992237WK8, 00000992321WK0, 00000992949WK8, 00000992952WK2, 00000993284WK9, 00000993807WK7, 00000994376WK2, 00000994685WK6, 00000994845WK6, 00000995791WK1, 00000995797WK8, 00000995798WK6, 00000995799WK4, 00000996181WK4, 00000996289WK5, 00000996290WK3, 00000996629WK2, 00000996739WK9, 00000996745WK6, 00000996977WK5, 00000997197WK9, 00000997198WK7, 00000997265WK4, 00000997333WK0, 00000997803WK2, 00000997808WK1, 00000997809WK9, 00000997885WK9, 00000997887WK5, 00000998455WK0, 00000998632WK4, 00000TA42184-1, 00001001026WK2, 00001001592WK3, 00001003410WK6, 00001003576WK4, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004158WK0, 00001004163WK0, 00001004330WK5, 00001004331WK3, 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00001013222WK3, 00001013223WK1, 00001013224WK9, 00001013225WK6, 00001013305WK6, 00001013306WK4 , 00001013334WK6, 00001013335WK3, 00001013336WK1, 00001013337WK9, 00001013621WK6, 00001013622WK4, 00001015809WK5, 00002UA5040SGX, 00002UA52707GV.

510(k) numbers

["K051967"]

PMA numbers

not on file

Product code

JAA

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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