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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution XR/d.

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 Class 2 Recall
Revolution XR/d.
see related information
Date Posted July 02, 2014
Recall Status1 Open
Recall Number Z-1989-2014
Recall Event ID 68528
Premarket Notification
510(K) Number
K012389 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product 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.
Code Information 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 CLAKEXRD 00000000002488 EBLUFFXRD 00000000004228 505784XRD 00000000004402 843390CON 00000000007854 864560IP3R 00000000003119 210292WHORT 00000000001454 303398XRD 00000000001050 312666VAHUM 00000000001148 312CCHER2 00000000001199 312CCHRAD4 00000000001156 312CCHRAD5 00000000001176 312CCHRAD6 00000000001230 312CCHRAD7 00000000001220 312CCHRAD8 00000000001464 314525SARM8 00000000001193 404321XRD 00000000001357 509942XRD 00000000001087 510372XRD 00000000002395 601264XRD1 00000000002086 605322XRD 00000000001792 605719XRD1 00000000001534 617726XR8Y3 00000000003984 631SLOANXRD 00001126 650493XRD 00000000001091 775786DR01 00000000001760 775885XRD 00000000001075 865545DR2 00000000001368 916366XRD 00000000001089 973971PED1 00000000002124 JAC1D33 00000000001323 JAC1D40 00000000001871 JAC3D13 00000000002239 JAC3E24 00000000002227 JAC3E48 00000000001887 JAC3E53 00000000004024 727893ER1 00000000001274 281338XDER2 00000000001940 509474XRD 00000000002001 415600XRD1 00000000001802 865481DR1 00000000001660 972566XRD1 00000000002675 601288XRD1 00000000001136 281338XD1 00000000001547 678945XRD 00000000001997 864560ER1 00000000001448 2027825A26 00000000003595 203694IC46 00000000001396 205592XRD1 00000000001218 205783PDR2 00000000001458 208737XRD 00000000002481 210646LXRD 00000000001795 212639XRD2 00000000002205 212639XRD3 00000000002560 217258SBER 00000000001666 217876DR8 00000000002296 225358XRD 00000000001621 229312MPXRD 00000000001643 229312MPXRD2 00000000001462 253426XRD1 00000000002000 253426XRD2 00000000022392 256265XR2 00000000002120 269983XRD 00000000002678 303932XRD 00000000001784 310319XRD 00000000001444 310319XRD2 00000000002949 310319XRD3 00000000003542 314251JDRM4 00000000002158 314525AIXRD1 00000000003356 314525AIXRD2 00000000001682 314525SARM5 00000000001580 314569SJCCX1 00000000007286 315449RAD2 00000000001683 317216XRD 0000000000AGA6 318456BRM2 00000000002661 330841XRD7 00000000001849 334293RADER 00000000001720 336713BCC1 00000000001952 336713BCC2 00000000001957 336713BCC4 00000000002125 336716BCR7 00000000001714 404686CRAD8 00000000002404 405271XRD 00000000002470 408236KSXRD2 00000000002564 408236KSXRD3 00000000002363 408236KSXRD7 00000000001318 409772ER2 00000000001853 409899RAD2 00000000003065 410605XRD1 0000FW21530260 412359XRD 00000000001723 415221XRD1 00000000002282 415353XRD1 00000000002502 419483DIGITAL1 00000000001247 423224DR2 00000000001876 423586DR1 00000000002588 503413LEXRD 00000000001874 504447XRD 00000000002462 507437XRD 00000000003045 509946XRD 00000000001375 515226XRD 00000000001413 515241XRD 00000000001710 515241XRD2 00000000002326 516562ERXRD1 00000000002307 518243RM7 00000000001570 518292XRD2 00000000001575 518292XRD3 00000000002427 520574XRD 00000000002889 520TMCXRD 0000000000A885 540332RM1 00000000001200 540332RM5 00000000003258 559325XRD 00000000002793 559459XRD2 00000000002373 570523XRD1 00000000001877 574523ER1 00000000002340 601426XRD1 00000000001057 602239ER2 00000000001635 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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action GE Healthcare sent an Urgent Medical Device Correction letter dated June 4, 2014, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in regard to this recall the consignees in the United States were advised to call 800-437-1171. For other countries contact your local GE Healthcare Service Representative. For questions regarding this recall call 800-437-1171.
Quantity in Commerce 1053
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = GE MEDICAL SYSTEMS, INC.
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