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U.S. Department of Health and Human Services

Class 2 Device Recall GE Precision 500D

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  Class 2 Device Recall GE Precision 500D see related information
Date Initiated by Firm August 13, 2007
Date Posted September 18, 2008
Recall Status1 Terminated 3 on October 07, 2010
Recall Number Z-1477-2008
Recall Event ID 49388
510(K)Number K011624  
Product Classification Image-intensified fluoroscopic x-ray system. - Product Code JAA
Product GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.
Code Information 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, 00001012884WK1, 00001012885WK8, 00001012888WK2, 00001012889WK0, 00001012991WK4, 00001012992WK2, 00001012993WK0, 00001012995WK5, 00001012996WK3, 00001012997WK1, 00001013087WK0, 00001013088WK8, 00001013089WK6, 00001013090WK4, 00001013102WK7, 00001013176WK1, 00001013177WK9, 00001013178WK7, 00001013179WK5, 00001013181WK1, 00001013182WK9, 00001013183WK7, 00001013184WK5, 00001013185WK2, 00001013293WK4, 00001013294WK2, 00001013298WK3, 00001013299WK1, 00001013302WK3, 00001013576WK2, 00001013577WK0, 00001013578WK8, 00001013579WK6, 00001013580WK4, 00001013581WK2, 00001013582WK0, 00001013583WK8, 00001013584WK6, 00001013585WK3, 00001013726WK3, 00001013728WK9, 00001013729WK7, 00001013731WK3, 00001013732WK1, 00001013733WK9, 00001013734WK7, 00001013735WK4, 00001013968WK1, 00001013969WK9, 00001013970WK7, 00001013974WK9, 00001013976WK4, 00001013977WK2, 00001014092WK9, 00001014093WK7, 00001014095WK2, 00001014097WK8, 00001014098WK6, 00001014099WK4, 00001014279WK2, 00001014280WK0, 00001014392WK3, 00001014394WK9, 00001014395WK6, 00001014397WK2, 00001014398WK0, 00001014549WK8, 00001014550WK6, 00001014551WK4, 00001014553WK0, 00001014556WK3, 00001014702WK3, 00001014703WK1, 00001014704WK9, 00001014705WK6, 00001014706WK4, 00001014707WK2, 00001014710WK6, 00001014711WK4, 00001014866WK6, 00001014953WK2, 00001014959WK9, 00001014960WK7, 00001014961WK5, 00001014962WK3, 00001015088WK6, 00001015092WK8, 00001015093WK6, 00001015096WK9, 00001015219WK7, 00001015220WK5, 00001015292WK4, 00001015293WK2, 00001015295WK7, 00001015297WK3, 00001015298WK1, 00001015559WK6, 00001015563WK8, 00001015689WK1, 00002AU53105K0, 00002UA4490WQG, 00002UA4490WQM, 00002UA4490WQV, 00002UA4510C3B, 00002UA4510C3J, 00002UA45200NH, 00002UA45200NM, 00002UA45200NR, 00002UA45200QY, 00002UA50306KL, 00002UA50306KT, 00002UA50306KW, 00002UA50306L6, 00002UA50306L7, 00002UA50306L8, 00002UA50306LD, 00002UA5030PTY, 00002UA5030PTZ, 00002UA5030PV2, 00002UA5040SH5, 00002UA504DSH3, 00002UA504OSH5, 00002UA5050FP7, 00002UA5080W88, 00002UA5080W89, 00002UA5100TCV, 00002UA510147Y, 00002UA51411JC, 00002UA51411JF, 00002UA51411JG, 00002UA51411JM, 00002UA51411JN, 00002UA51411JT, 00002UA51411JY, 00002UA51411JZ, 00002UA51604QS, 00002UA51604QV, 00002UA51604QY, 00002UA51604R2, 00002UA51604R3, 00002UA51604R4, 00002UA51604R6, 00002UA51604R9, 00002UA51604RH, 00002UA51701BZ, 00002UA51701C2, 00002UA51701C5, 00002UA51701C6, 00002UA51701C8, 00002UA51701CH, 00002UA52111XQ, 00002UA52111XR, 00002UA52111XS, 00002UA52111XT, 00002UA52111XV, 00002UA52111XW, 00002UA52111XX, 00002UA5220564, 00002UA5220BKM, 00002UA5220BKP, 00002UA5220BKV, 00002UA5220S5X, 00002UA5220S5Y, 00002UA5220S5Z, 00002UA5220S62, 00002UA5220S63, 00002UA52606Q5, 00002UA52606QC, 00002UA52606QD, 00002UA52707GY, 00002UA52707GZ, 00002UA527115R, 00002UA527115V, 00002UA527115Z, 00002UA5290DD1, 00002UA5290DD2, 00002UA53006LM, 00002UA53006LN, 00002UA53006LP, 00002UA53006LR, 00002UA53006LS, 00002UA53006LT, 00002UA53006LV, 00002UA5320FKJ, 00002UA5320FKM, 00002UA5320FKN, 00002UA5320FKR, 00002UA53405P5, 00002UA53405P7, 00002UA53405P9, 00002UA53405PG, 00002UA5340LCV, 00002UA5340LCY, 00002UA5340VDC, 00002UA5340VDG, 00002UA5340VDK, 00002UA5340VDL, 00002UA535112H, 00002UA5360CBD, 00002UA5360CBG, 00002UA5360CBM, 00002UA5360CBN, 00002UA53707WM, 00002UA53707WQ, 00002UA53707WR, 00002UA53802GP, 00002UA5400VB7, 00002UA5400VB8, 00002UA541113W, 00002UA541113X, 00002UA5411140, 00002UA5411142, 00002UA5411143, 00002UA5411144, 00002UA5411146, 00002UA5411147, 00002UA5411148, 00002UA5411149, 00002UA541114B, 00002UA541114H, 00002UA542046N, 00002UA542046P, 00002UA542046Q, 00002UA542046R, 00002UA542046T, 00002UA542046V, 00002UA5420VPK, 00002UA5420VPM, 00002UA5420VPP, 00002UA5430X4Y, 00002UA5440B2V, 00002UA5440B2W, 00002UA5450SNN, 00002UA5450SNR, 00002UA5450SNY, 00002UA60200GH, 00002UA606KJH4, 00002UA606KJH7, 00002UA615JV3C, 0000USU4350N51, 0000USU4400NXF, 0000USU4400NXJ, 0000USU4400NXQ, 0000USU4400NXV, 0000USU4400NXW, 0000USU4400NXY, 0000USU4400NY0, 00010103324WK3, 0UNK2289299-01, , 00000114134VE0.
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall		 Necessary certification labels are missing from the x-ray contol.
FDA Determined
Cause 2		 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 in Commerce 437
Distribution Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.
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 = JAA and Original Applicant = GE MEDICAL SYSTEMS
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