Device Recall Revolution XR/d

Mfg Lot or Serial # System ID 00000000001837 815338WXRD 00000000002821 815759RAD2 00000000003407 205206SWXRD1 00000000001153 205838AXRD1 00000000003535 205939SVER 00000000002574 209669XRD 00000000001745 215481DR19 00000000001320 215481DR21 00000000001315 215481DR2BLAIR 00000000002962 215481XRDER1 00000000003098 251435XRD1 00000000003049 251435XRD2 00000000001366 406496XRD 00000000001380 413447XRD 00000000002377 417347ED1 00000000002584 417451NMC 00000000002257 503GICXRD 00000000002243 505834XRD 00000000002458 516IPKXRD 00000000003171 567661XRD 00000000002865 601443XRD1 00000000002007 606549XRD 00000000002590 618993MDRF 00000000002378 630236XRD 00000000002722 630275ERXRD 00000000002480 630856ER1 00000000003347 708783R8 00000000003524 757886ER 00000000001026 773MTSXRD1 00000000003954 814868RAD 00000000003465 815740XRDER 00000000002414 815933XRD2 00000000002501 847437GEXRD3 00000000003112 850474XRD 00000000002839 850474XRD2 00000000002054 928669XRD 00000000002688 985230RAD4 00000000002869 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082407160205 FMITR170990116 082407200030 FMITR170990117 082407250031 FMITR170990118 082407270077 FMITR170990131 082403100013 FMITR170990299 082407160172 00000000002055 600110RX04 00000000002542 CS1020RX02 00000000002622 CS1020RX03 00000000002751 2585811REVO 00000000003557 X4211021 00000000003415 M4489633 00000000007683 M2842566 00000000002580 M4499017 FMITR170990016 R4211484 FMITR170990021 A4166945 FMITR170990022 M9164741 FMITR170990023 R4211469 FMITR170990024 M5460629 FMITR170990025 A4166941 FMITR170990033 M5460650 FMITR170990147 M4162512 FMITR170990148 M1460208 FMITR170990266 M4198028 FMITR170990289 M4197637 FMITR170990306 0002565632A FMITR170990307 0002565636A FMITR170990891 X62750603 00000000002118 423738XR03 00000000001102 HC3904XR01 00000000002654 CC0618XR12 00000000001972 HC0030XR10 00000000002878 484127XR02 00000000002478 PC8740XR01 00000000002515 UHAN01XR10 FMITR170990136 623912XR01 FMITR170990138 CC0618XR16 FMITR170990140 PC7479XR04 FMITR170990287 HC1770XR09 FMITR170990288 PC3817XR01 00000000003263 0828070105 FMITR170990284 0828070102 FMITR170990321 0828070103 00000000001729 HU1008RX15 00000000003245 HU1099RX16 FMITR170990986 HU1025RX15 00000000002668 IQ1034RX01 00000000002998 IQ1039RX01 00000000002518 IQ1124RX01 00000000002435 IQ1128RX01 00000000002888 IQ1263RX01 00000000002944 IQ1300RX01 00000000002981 IQ1326RX01 00000000002855 IQ1346RX02 00000000002681 IQ1391RX01 FMITR170990989 IQ1001RX01 FMITR170990990 IQ1050RX02 FMITR170990991 IQ1053RX01 FMITR170990992 IQ1165RX01 FMITR170990993 IQ1261RX01 FMITR170990994 IQ1305RX01 FMITR170990995 IQ1316RX01 FMITR170990996 IQ1359RX01 FMITR170990066 IE1006RX08 FMITR170990139 IE1094RX01 FMITR170990846 IE6000RX01 FMITR170990987 IE1053RX02 00000000001140 IL1098RX01 00000000002571 IL1000RX04 FMITR170990297 IL1062XR05 FMITR170990988 IL1000XR03 00000000001Q21 A5145732 00000000001111 F5119123 00000000001180 A51043119 00000000002439 H5382007 FMITR170990137 A5105149 FMITR170990149 B5167310 FMITR170990165 B5119112 FMITR170990263 A5141714 FMITR170990264 D5249922 FMITR170990273 B5167311 FMITR170990291 C5343109 FMITR170990317 A5183761 FMITR170990923 A5102660 FMITR170990959 A5605736 FMITR170990960 A5605738 FMITR170990977 A5120523 FMITR170990983 A5303320 FMITR170990984 A5815416 00000000001054 XQ0026 00000000007298 XQ0035 00000000001913 XQ0066 00000000001108 XQ0018 00000000001103 XQ0023 00000000001060 XQ0028 00000000001422 XQ0036 00000000001814 XQ0052 00000000002299 XQ0057 00000000001096 XQ0027 00000000001406 XQ0056 00000000001104 XQ0059 00000000001197 XQ0065 00000000002461 XK0001 00000000002898 XK0002 00000000002600 XK0003 00000000002505 XQ0068 FMITR170990275 XQ0022 FMITR170990276 XQ0055 FMITR170990283 XQ0076 FMITR170990302 XQ0063 FMITR170990303 XQ0101 FMITR170990304 XQ0110 FMITR170990921 XK0005 FMITR170990922 XK0006 FMITR170990973 XK0007 00000000001954 0850070702 0000000000AG38 0850070714 00000000001870 0850070715 00000000002443 0850070726 00000000002875 0850070733 00000000002985 0850070734 00000000002665 0850070736 FMITR170990027 0850070704 FMITR170990028 0850070718 FMITR170990029 0850070730 FMITR170990030 0850070731 FMITR170990031 0850070735 FMITR170990032 0850070738 00000000002160 KW1006RX10 00000000001908 KW1006RX09 00000000002179 KW1007RX02 00000000002624 KW1077XR02 FMITR170990305 KW1001RX10 FMITR170990938 KW1018RX07 FMITR170990997 LV4000RX01 FMITR170990035 LB1050XR01 FMITR170990130 LB1050RX01 FMITR170990976 LB1076RX02 00000000002371 MT1014RX01 00000000002410 MT1014RX02 00000000002417 MT1014RX05 00000000002400 MT1014RX03 00000000002289 MT1014RX04 FMITR170990123 BMALTA03 FMITR170990124 BMALTA04 FMITR170990125 BMALTA07 FMITR170990300 BMALTA05 FMITR170990301 BMALTA06 00000000002606 RTD0984 FMITR170990164 TLB0207 00000000001196 NO1095RX03 00000000002073 RU2210RX01 00000000001062 SA1011RX04 00000000001412 SA1042RX07 00000000001762 SA1012RX13 00000000001694 SA1012RX14 00000000001419 SA1012RX15 00000000001143 SA1012RX06 00000000001747 SA1012RX12 00000000002740 SA1013RX01 00000000003036 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ME504361 FMITR170990937 CEE15654 FMITR170990975 FPG86410 FMITR170990323 FA00RX01 FMITR170990998 O005RX17 FMITR170990974 387040XR08 00000000001018 0853070248 00000000001273 0853070260 00000000001764 0853070295 00000000002899 0853070321 FMITR170990119 0853070255 FMITR170990120 0853070271 FMITR170990121 0853070312 FMITR170990122 0853070314 FMITR170990329 60001RAD02 FMITR170990925 06004RAD05 FMITR170990939 06014RAD01 FMITR170990267 UG1025RX01 FMITR170990145 AE1026RX02 FMITR170990271 AE1104RX01 00000000001240 10433RAD01 00000000001242 10433RAD02 00000000001392 05262RAD01 00000000002545 IE1564RX02 FMITR170990142 00487RAD03 FMITR170990285 77069RAD02 FMITR170990045 388259146XRMET FMITR170990046 38864650XRMET FMITR170990047 38897737XRMET

Radiology Devices

2

No

Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.

GE Healthcare, Revolution XR/d. || Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

SERIAL 00001002491WK7 00000100291WK7 00000999999WK6 00001001816WK6 00001001824WK0 00000995364WK7 00000996497WK4 00000068396WG1 00000995361WK3 00000996218WK4 00000001239M33 00001000600WK5 00000996216WK8 00000001247M36 00000998382WK6 00001001814WK1 00000995360WK5 00001004793WK4 00000998805WK6 00000994499WK2 00001006377WK4 00000997607WK7 00000999065WK6 00001004294WK3 00001005696WK8 00000998799WK1 00000997599WK6 00000992542WK1 00000069597WG3 00001004299WK2 00001002488WK3 00001002487WK5 00000998941WK9 00000998939WK3 00000995356WK3 00000993793WK9 00001000954WK6 00001001827WK3 00000998388WK3 00001005678WK6 00001003046WK8 00001001837WK2 00000035324HL3 00000997608WK5 00001002486WK7 00000998945WK0 00000995366WK2 00000998391WK7 00000994494WK3 00000993374WK8 00000037897HL6 00000001238M35 00000999698WK4 00001003557WK4 00000998383WK4 00001002483WK4 00000999993WK9 00001000956WK1 00000998386WK7 00000997605WK1 00000997602WK8 00000998938WK5 00001001810WK9 00000996491WK7 00001001085WK8 00000035064HL5 00001002490WK9 00001000950WK4 00000996495WK8 00000996791WK0 00000996500WK5 00000996209WK3 00000994488WK5 00000034881HL3 00001000951WK2 00001001799WK4 00001003566WK5 00001003045WK0 0000USU4400NXJ 00000997069WK0 00001002489WK1 00000996498WK2 00001001811WK7 00001000958WK7 00000998392WK5 00000996792WK8 00001004296WK8 00000998944WK3 00001001800WK0 00001003561WK6 00000995353WK0 00001001818WK2 00001005004WK5 00000998937WK7 00000996499WK0 00001002482WK6 00000996212WK7 00001003553WK3 00001000000WK8 00000995349WK8 00000996684WK7 00000998156WK4 00001004304WK0 00000036505HL6 00000994505WK6 00001000952WK0 00000997182WK1 00000998804WK9 00000995368WK8 00000995357WK1 00000994491WK9 00001001807WK5 00000999998WK8 00001005694WK3 00000993794WK7 00001000955WK3 00000064580WG4 00001001822WK4 00001003554WK1 00000998942WK7 00000996789WK4 00001004791WK8 00000996227WK5 00000001173M34 00001000957WK9 00000081110MA9 00001004139WK0 00001004298WK4, and 0000000069365W.

Radiology Devices

2

No

Nationwide Distribution -- AL, AZ, CA, CO, FL, GA, HI, IL , IN, KY, LA, MD, MA, MI,MN,MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN, TX, VA, WA, and WV.

Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434

SYSTEM 418525XRD 905575XRD 630856QXI 847437GEXRD3 847437XRDCH 605622RAD 850208XRD 217223XRD 269657XRD 415600XRD3 724873XRDL 615342ERXRD 615342RM1 205939SVXRD 716250RAD1 919575FCI2 919575LSCI 724458XRD 850934XRD 303932XRD 303932XRD 760241XRD 256265XR2 256265XR3 256IXR1 251435XRD1 208743LXRDX 318675ACCR1 318675ACCR2 708783R8 602506XRD 724773XRDL 843573WAXRD 713605XRD 562424XRD 954987PED1 713790MMXRD1 281274XRD2 865481FTXRD 630236XRD 949364ER 210646LXRD 781344XRD 567661XRD 630978XRDE185 630978XRDE186 805494XRD 847429ERT 440816XRD1 253952XRD1 314251JDRM4 636947XRDER 205408SVXRD 813654XRD 715393XRD 330841XRD7 330841XRD9 209669XRD 209669XRD 812238UH2 216844PEDR2 910822VAXRD2 205387WDC 503315WOXRD 803776VR1 XQ0068 XK0002 XK0003 XQ0076 XK0005 XK0006 XK0007 XK0001 082407040266 082407160202 0853070321 0850070730 0850070733 0850070734 0850070735 0850070736 0850070731, and 0850070738.

Radiology Devices

2

No

Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, ID, IL, IN, LA, MA, MI, MO, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA, and WI and countries of Canada, China, Japan, Korea, and Taiwan.

Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. || Intended for use in generating Tomographic images of human anatomy.