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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 Device Recall Revolution XR/d. see related information
Date Initiated by Firm June 04, 2014
Date Posting Updated July 02, 2014
Recall Status1 Terminated 3 on May 06, 2015
Recall Number Z-1989-2014
Recall Event ID 68528
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 D, 00000000002642 360493DR2, 00000000002559 360493DR3, 00000000002151 402449CXRD1, 00000000002005 412942XRD, 00000000002171 419483DIGITAL2, 00000000002572 716250RAD1, 00000000002367 912920XRD, 00000000002424 216844PEDR2, 00000000003300 541667XRD, 00000000002396 570969XRD, 00000000002997 609835XRD, 00000000002928 636947XRDER, 00000000002897 763689XRD, 00000000002972 865425XRD1, 00000000001461 949364ER, 00000000003351 205554VAXRD1, 00000000002894 213485XRD, 00000000002586 228818OSXRD, 00000000002766 253952XRD1, 00000000001186 281420XRDL, 00000000003818 281943DRAD, 00000000002977 301784FCI, 00000000002959 303320XRD1, 00000000003097 304379XRD, 00000000004093 305662ORTHO1, 00000000001749 310319XRDER1, 00000000003268 313343XRD1, 00000000002522 313593XRD1, 00000000003497 314251JDHC1, 00000000003513 314251JDHC2, 00000000003184 318335XRD, 00000000002995 318675ACCR1, 00000000002447 318675ACCR2, 00000000002809 330489XRD, 00000000002472 336716BCR1, 00000000002780 336716BCR3, 00000000002676 337261UXRD1, 00000000003930 337261UXRD2, 00000000002887 402336XRD, 00000000003975 432685DDR3, 00000000003313 503215BRXRD, 00000000003319 503215ERXRD, 00000000002948 509474XRDTR1, 00000000002828 540776XRD4, 00000000003966 541677MDR1, 00000000003962 541677MDR2, 00000000002655 570547FCIM, 00000000003225 573884XRAY, 00000000003463 573UPMBXR, 00000000003107 601984XRD1, 00000000003337 605322XRDER, 00000000003035 609597XRD, 00000000002881 610648XRD5, 00000000003570 610916LIMRAD1, 00000000002539 617414XRD2, 00000000003178 617638DR4, 00000000002842 617754XRD3, 00000000002834 620429RAD, 00000000002721 631727XRD, 00000000003023 703698D8000, 00000000001933 704384XRD, 00000000003358 706733VAUD1, 00000000002988 713605XRD, 00000000002697 719560DR1, 00000000002825 724458XRD, 00000000002656 724772XRDL, 000010507177AD 734467XRD, 00000000003005 763780XRD, 00000000002500 813571ER, 00000000003044 817551OPR1, 00000000002975 818907RAD1, 00000000002581 847429ERT, 00000000003108 847842OP1, 00000000001157 850934XRD, 00000000002453 859313XRD2, 00000000003277 919575FCI2, 00000000003448 919575LSCI, 00000000002816 928779RM1, 00000000003252 970247EDXRD, 00000000003241 970247RADXRD, 00000000003340 972981D8K6, 00000000001818 972981D8K7, 00000000003391 972981D8K8, 00000000003700 716250CH1, 00000000003437 225869XRD, 00000000003424 408363VATHU1, 00000000002651 602506XRD, 00000000002440 615342ERXRD, 00000000002996 615342RM1, 00000000003289 617414LTG2, 00000000003380 660827BR2, 00000000003141 706494HC4, 00000000003205 706571MCXR, 00000000003383 706884HCL, 00000000002519 715393XRD, 00000000003318 724773XRDL, 00000000003330 724873XRDL, 00000000003388 724873XRDL2, 00000000003159 732545DR1, 00000000002863 781344XRD, 00000000002614 805494XRD, 00000000002851 847437XRDCH, 00000000002884 850208XRD, 00000000001544 850434XRD, 00000000001161 864512XRD, 00000000003272 865481FTXRD, 00000000002260 734712RM1, 00000000003027 903XRDFCIPRISON, FMITR170990001 203573XRD, FMITR170990002 205387WDC, FMITR170990003 206320EHXR, FMITR170990004 229312PER, FMITR170990005 269657XRD, FMITR170990006 309454BXRD, FMITR170990007 310315SJXRD1, FMITR170990008 503315WOXRD, FMITR170990009 609953XRD, FMITR170990010 740592R1, FMITR170990011 757983RM1, FMITR170990012 773MTSXRDER, FMITR170990013 850934XRDA, FMITR170990014 931685XRD, FMITR170990015 815477CLXRD, FMITR170990018 920303XQI, FMITR170990019 281338XDER, FMITR170990020 314525ARM19A, FMITR170990036 713973HDQXI, FMITR170990044 ECXR1405B, FMITR170990049 210297SLBXRD, FMITR170990050 312996UCON, FMITR170990051 312996UHUM, FMITR170990052 404686CRAD1, FMITR170990053 409899RAD1, FMITR170990055 509473DR3, FMITR170990057 617726XR9Y3, FMITR170990058 650497CHXRD2, FMITR170990059 708425XRD1209, FMITR170990060 727298ER1, FMITR170990061 773967XRD3, FMITR170990062 918744JDR1, FMITR170990063 JAC1D45, FMITR170990064 JESSEBROWNADMIN, FMITR170990065 404501DICXRD, FMITR170990067 601883XRD, FMITR170990128 216844XRD3, FMITR170990129 715833XRD, FMITR170990132 415668XRD1, FMITR170990135 615264ER1.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
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
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 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 = KPR and Original Applicant = GE MEDICAL SYSTEMS, INC.
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