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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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.

all serial numbers

Radiology Devices

2

No

Worldwide Distribution.

GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 || Model numbers: 2259988-2 & 2351505. || 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 system 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