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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 Posted July 02, 2014
Recall Status1 Terminated 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
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00000000001157 850934XRD
00000000002453 859313XRD2
00000000003277 919575FCI2
00000000003448 919575LSCI
00000000002816 928779RM1
00000000003252 970247EDXRD
00000000003241 970247RADXRD
00000000003340 972981D8K6
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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
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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 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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