Reported Oct 23, 2013 · Terminated
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
- Lot codes and dates
- Serial # System IDNot Available
429 of 429 codes
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Not Available229 of 229 codes
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Not Available00001030123WK2301891P50000001030234WK7217222QP50000001030299WK0269945P50000001030300WK6910862P500D00001030301WK4
Not Available00001030302WK2918286P50000001030303WK0320845P50000001030458WK2309944HH50000001030459WK0817865FPSP50000001030460WK8615329PP50000001030461WK6610284P50000001030462WK4937641RMF00001030580WK3662OBRF00001030581WK1402484AP50000001030582WK9229276CRF100001030583WK7
Not Available 00001030897WK1 808YMP500D 00001030898WK9 303DCIP500 00001030981WK3 Not Available 00001030982WK1 309672P500D2 00001030983WK9 MIMCP500D 00001031089WK4 Not Available 00001031090WK2 Not Available 00001031091WK0 Not Available 00001031092WK8 Not Available 00001031257WK7 Not Available 00001031442WK5 Not Available00001030584WK5601663P50000001030634WK8276988P50000001030696WK7361580P50000001030697WK5504903P50000001030699WK1408351600001030700WK7909796P50000001030701WK5269637P50000001030895WK5801657P50000001030896WK3
Not Available 00001024723WK7 Not Available 00001024724WK5 503623RF1 00001024745WK0 401782SCP500 00001024746WK8 516663RMP5 00001024747WK6 Not Available 00001024748WK4 Not Available 00001024878WK9 605997P500 00001024879WK7 Not Available 00001024880WK5 605747P500 00001024881WK3 605867P500 00001024882WK1 Not Available00001025587WK5CANFPRECRX100001027088WK2PC0362XR1200001026426WK5GH1042RX0200001027865WK3XR1027865WK300001030698WK3XR23354M3400001028160WK8YX128500001025369WK8AE1021RX0400001027096WK5412372P500D00001025507WK3561955RF00000102474WK4804287P50000001024519WK9203739P50000001024520WK7717272RF300001024572WK8405271CCP50000001024573WK6650493VARF200001024574WK4281MWP50000001024575WK1504842RM300001024676WK7707464RF200001024677WK5
Not Available 00001025577WK6 407518PRE 00001025578WK4 Not Available00001025005WK8607547RF200001025006WK6RADNETRF126800001025007WK4757312RM400001025008WK2RADNETRF126900001025009WK0813571RM400001025010WK8RADNETRF127000001025049WK6LLPM500D00001025050WK4207564P50000001025051WK2315338RF00001025052WK0931520P50000001025054WK6630275G0500001025258WK3985646RF400001025260WK9912367AURORA00001025261WK7907PIC2P50000001025371WK4918224P500D100001025372WK2818409RF200001025373WK0954JDCHRF100001025374WK8210BMCRF100001025375WK5270251JPRF200001025508WK1508862CCR300001025509WK9212420ENDO100001025510WK7859498P50000001025511WK5954JDCHRF200001025573WK5918744P5RM300001025574WK3205408SVRF00001025575WK0412623P500D100001025576WK8
Not Available00001025579WK2719285P50000001025582WK6434447CMRM400001025876WK2229P500RF100001025877WK0918744P5RM400001025878WK8606439P50000001025879WK6954265ME100001025880WK4518926FLRM400001025886WK1606633P50000001025887WK9606237PRE00001025888WK7203739RM400001025889WK5269789P50000001025890WK3229P500RF200001025977WK8
Not Available00001025978WK6210MTRF100001025988WK5701252P50000001026027WK1434654RM300001026028WK9903CSMP50000001026029WK7
Not Available 00001026259WK0 Not Available00001026030WK5559459500D00001026031WK3978683LGRF500001026146WK9434654RM400001026147WK7907442KP50000001026148WK5704829P50000001026250WK9504632P50000001026251WK7585596P50000001026252WK5208463P500D00001026253WK3520GV500D00001026254WK1713873P500D00001026255WK8727848P5D200001026256WK6727848P5D100001026257WK4936539P500D200001026258WK2
Not Available 00001026643WK5 561745RM4 00001026709WK4 412623P500D2 00001026710WK2 276228P500 00001026711WK0 Not Available00001026260WK8RADNETRF18200001026264WK0781624HSSHRF00001026467WK9202269P500300001026468WK7717270RF200001026469WK5409938P50000001026470WK3360754ICRF00001026471WK1COR48136000001026472WK9903GS50300001026473WK7406293P50000001026474WK5SLRP500FP100001026640WK1541382RM300001026641WK9540SHENP50000001026642WK7
Not Available105 of 105 codes
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
Not Available81 of 81 codes
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
Not Available93 of 93 codes
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Not Available 00001030891WK4 718226VZRM2 00001030892WK2 Not Available00001030467WK3740633P50000001030577WK9618288RM200001030578WK7978741SRF300001030579WK5724772P500D100001030704WK9217383P500A00001030705WK6704667RF100001030707WK2501202P500RM200001030708WK0UICGERF100001030709WK8863763RM100001030710WK6478PCHP50000001030711WK4
910FHHOKE+P500 00001031197WK5 Not Available 00001031198WK3 Not Available 00001031259WK3 Not Available 00001031260WK1 Not Available 00001031312WK0 Not Available 00001031313WK8 Not Available 00001031314WK6 Not Available 00001031315WK3 Not Available 00001031316WK1 Not Available00001030893WK0505WHRM100001030894WK8408885FL100001030985WK4570621SEPREC00001030986WK2941629P50000001031093WK6757889RM400001031094WK4937734PRE00001031095WK1281420SJM500D100001031096WK9937641RMA00001031196WK7
Not Available82 of 82 codes
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
N/A 206386RF1 N/A 212646PREC N/A 281351TLEG N/A 281890MWRF N/A 318448COP2 N/A 404571DL1 N/A 408885LEG1 N/A 512341RRF1 N/A 605665FL N/A 606723XR2 N/A 606836BX3A N/A 610284RF1 N/A 612758RF N/A 616781RF2 N/A 618288ARF2 N/A 702255RF2 N/A 717765RF1 N/A 718667PRM3 N/A 813725RF1 N/A 813432RF1 N/A 815786D5K N/A 906226DMR2 N/A 912273CR1 N/A 931879JRF2 N/A 956721RF1 Not Available 0002872736 Not Available 202745PRE Not Available 203688P500 Not Available 205286BRF Not Available 214345PRF Not Available 254562RF1 Not Available 262OLCGOC1A Not Available 270417RF1 Not Available 407649LG2 Not Available 414777MP2 Not Available 504652RP2 Not Available 573760PR1 Not Available 580251ROOM1 Not Available 601268W5 Not Available 609835P500 Not Available 610284PRO2 Not Available 610284RF3 Not Available 617726RF4E2 Not Available 706754HR2 Not Available 713770THUNDER Not Available 717267RF6 Not Available 815740XRDER Not Available 909GERF1 Not Available 912466P1207 Not Available 928537RM1 Not Available 956632RCR Not Available 973972C308 Not Available DCOSDI000000011 Not Available DCOSDI000000018 Not Available DCOSDI000000222 Not Available DCOSDI000000703 Not Available DCOSDI00001717 Not Available DCOSDI00001740 Not Available DCOSDI00001752 Not Available DCOSDI100000008 Not Available DCOSDI100000043 Not Available DCOSDI100000152 Not Available DCOSDI100000272 Not Available DCOSDI100000412 Not Available DCOSDI100000700 Not Available DCOSDI100000820 Not Available DCOSDI110000289 Not Available DCOSDI140000071 Not Available DCOSDI200000107 Not Available DCOSDI200001358 Not Available DCOSDI300000408 Not Available DCOSDI300000436 Not Available DCOSDI300000440 Not Available DCOSDI300000920 Not Available DCOSDI400000063 Not Available DCOSDI400000167 Not Available DCOSDI50000419 Not Available DCOSDI50000425 Not Available DCOSDI50000426 Not Available DCOSDI600000212 Not Available KPICT Not Available LBDEMO2 Not Available RADNETRF1206 Not Available RADNETRF1213 Not Available RADNETRF1225 Not Available RADNETRF1240 Not Available RADNETRF1254 194130WK1 RADNETRF186 Not Available 416284LS16 Not Available 506648L9A Not Available 514934BRAD363 of 63 codes
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
- Serial # System ID
- Amount recalled
- 810 (783 US, 27 OUS)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- DC
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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