FDA · Medical device recall

GE Definium 8000… and 1 more product

Sept. 18, 2008

Date posted by the FDA: Sept. 18, 2008
Status: Terminated
Filed by: GE Healthcare
Reason: Necessary certification labels are missing from the x-ray contol.
Distribution pattern: Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.

2 products in this recall

GE Definium 8000…

Product: GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.
Quantity: 448
Codes and lots: 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, 00001004332WK1, 00001004504WK5, 00001004770WK2, 00001004771WK0, 00001004772WK8, 00001004884WK1, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005020WK1, 00001005021WK9, 00001005022WK7, 00001005023WK5, 00001005024WK3, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005030WK0, 00001005031WK8, 00001005033WK4, 00001005034WK2, 00001005179WK5, 00001005181WK1, 00001005184WK5, 00001005188WK6, 00001005260WK3, 00001005698WK4, 00001005757WK8, 00001005762WK8, 00001005764WK4, 00001005841WK0, 00001005912WK9, 00001006015WK0, 00001006040WK8, 00001006043WK2, 00001006044WK0, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006474WK9, 00001006475WK6, 00001006476WK4, 00001006633WK0, 00001006637WK1, 00001006664WK5, 00001006666WK0, 00001006668WK6, 00001006822WK9, 00001006833WK6, 00001006871WK6, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007161WK1, 00001007162WK9, 00001007165WK2, 00001007166WK0, 00001007192WK6, 00001007476WK3, 00001007478WK9, 00001007498WK7, 00001007499WK5, 00001007517WK4, 00001007525WK7, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007563WK8, 00001007642WK0, 00001007643WK8, 00001007644WK6, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007651WK1, 00001007715WK4, 00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007776WK6, 00001007781WK6, 00001007785WK7, 00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9, 00001007907WK7, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008312WK9, 00001008313WK7, 00001008314WK5, 00001008315WK2, 00001008316WK0, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008684WK1, 00001008686WK6, 00001008687WK4…
Recall started: Aug. 13, 2007
Device type: System, X-Ray, Fluoroscopic, Image-Intensified
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: A field Engineer from GE will visit the customer site to apply label to the X-ray control.
Recall number: Z-1476-2008

GE Precision 500D…

Product: GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.
Quantity: 437
Codes and lots: serial numbers: 00001014958WK1, 100963570, 00000086203DP7, 00000086475DP1, 00000086507DP1, 00000089131DP7, 00000993365WK6, 00000994505WK6, 00000995353WK0, 00000996209WK3, 00000996212WK7, 00000996789WK4, 00001000009WK9, 00001002273WK9, 00001002491WK7, 00001009077WK7, 00001009774WK9, 00001009986WK9, 00001010013WK9, 00001010015WK4, 00001010016WK2, 00001010017WK0, 00001010018WK8, 00001010020WK4, 00001010021WK2, 00001010059WK2, 00001010060WK0, 00001010061WK8, 00001010062WK6, 00001010063WK4, 00001010064WK2, 00001010065WK9, 00001010066WK7, 00001010068WK3, 00001010091WK5, 00001010120WK2, 00001010208WK5, 00001010209WK3, 00001010210WK1, 00001010212WK7, 00001010213WK5, 00001010214WK3, 00001010216WK8, 00001010217WK6, 00001010287WK9, 00001010328WK1, 00001010329WK9, 00001010330WK7, 00001010333WK1, 00001010334WK9, 00001010335WK6, 00001010336WK4, 00001010337WK2, 00001010550WK0, 00001010551WK8, 00001010552WK6, 00001010553WK4, 00001010554WK2, 00001010555WK9, 00001010739WK9, 00001010741WK5, 00001010743WK1, 00001010744WK9, 00001010746WK4, 00001010747WK2, 00001010748WK0, 00001010854WK6, 00001010855WK3, 00001010856WK1, 00001010859WK5, 00001010860WK3, 00001010861WK1, 00001010862WK9, 00001010863WK7, 00001011010WK4, 00001011011WK2, 00001011012WK0, 00001011013WK8, 00001011014WK6, 00001011029WK4, 00001011030WK2, 00001011031WK0, 00001011033WK6, 00001011035WK1, 00001011036WK9, 00001011037WK7, 00001011200WK1, 00001011201WK9, 00001011202WK7, 00001011203WK5, 00001011204WK3, 00001011205WK0, 00001011206WK8, 00001011207WK6, 00001011208WK4, 00001011209WK2, 00001011320WK7, 00001011321WK5, 00001011327WK2, 00001011328WK0, 00001011341WK3, 00001011342WK1, 00001011343WK9, 00001011344WK7, 00001011345WK4, 00001011346WK2, 00001011347WK0, 00001011348WK8, 00001011349WK6, 00001011513WK7, 00001011514WK5, 00001011515WK2, 00001011516WK0, 00001011517WK8, 00001011518WK6, 00001011519WK4, 00001011520WK2, 00001011521WK0, 00001011657WK2, 00001011762WK0, 00001011763WK8, 00001011764WK6, 00001011765WK3, 00001011766WK1, 00001011767WK9, 00001011768WK7, 00001011769WK5, 00001011770WK3, 00001011875WK0, 00001011876WK8, 00001011877WK6, 00001011878WK4, 00001011879WK2, 00001011887WK5, 00001011888WK3, 00001011889WK1, 00001011890WK9, 00001011891WK7, 00001012024WK4, 00001012025WK1, 00001012026WK9, 00001012027WK7, 00001012028WK5, 00001012029WK3, 00001012030WK1, 00001012031WK9, 00001012032WK7, 00001012033WK5, 00001012176WK2, 00001012177WK0, 00001012178WK8, 00001012179WK6, 00001012180WK4, 00001012181WK2, 00001012182WK0, 00001012183WK8, 00001012186WK1, 00001012187WK9, 00001012188WK7, 00001012189WK5, 00001012190WK3, 00001012191WK1, 00001012192WK9, 00001012193WK7, 00001012194WK5, 00001012195WK2, 00001012432WK9, 00001012434WK5, 00001012435WK2, 00001012499WK8, 00001012500WK3, 00001012501WK1, 00001012502WK9, 00001012503WK7, 00001012505WK2, 00001012506WK0, 00001012508WK6, 00001012541WK7, 00001012542WK5, 00001012543WK3, 00001012546WK6, 00001012547WK4, 00001012548WK2, 00001012549WK0, 00001012881WK7, 00001012883WK3…
Recall started: Aug. 13, 2007
Device type: System, X-Ray, Fluoroscopic, Image-Intensified
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: A field Engineer from GE will visit the customer site to apply label to the X-ray control.
Recall number: Z-1477-2008

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1476-2008, Z-1477-2008. The agency record governs; check it and the company before acting.

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