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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus XR/a

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  Class 2 Device Recall Proteus XR/a 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-1988-2014
Recall Event ID 68528
510(K)Number K993090  
Product Classification System, x-ray, stationary - Product Code KPR
Product GE Healthcare, Proteus XR/a.

Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Code Information FMITR170990555 620375ER1, FMITR170990556 620378RAD, FMITR170990557 623327ER1, FMITR170990558 630652PROT, FMITR170990559 630933PROT2, FMITR170990561 660882CRMB, FMITR170990562 660890GVCHEST, FMITR170990563 703478PROT1, FMITR170990564 703709RAD, FMITR170990565 706736AORAD, FMITR170990567 707554RAD1, FMITR170990568 708747ER, FMITR170990569 708756ER1, FMITR170990570 713566SRAD3, FMITR170990571 713566SRAD4, FMITR170990572 713566SRAD7, FMITR170990573 713566SRAD8, FMITR170990574 713704OPRAD2, FMITR170990575 715735RAD1, FMITR170990576 715743PR1, FMITR170990577 716326RAD1, FMITR170990578 716477RAD, FMITR170990579 716689RAD1, FMITR170990580 717531TRAUMA1, FMITR170990581 717531TRAUMA2, FMITR170990582 717SHCR1, FMITR170990583 717SHCR2, FMITR170990584 718780RAD2, FMITR170990585 718960PROTEUS, FMITR170990586 719264RAD, FMITR170990587 720SAER2, FMITR170990588 720SAER3, FMITR170990589 720SAOR10, FMITR170990591 731968RM2, FMITR170990592 732222ER2, FMITR170990593 732530URG, FMITR170990594 734712T1, FMITR170990595 734712T2, FMITR170990596 757889MM2, FMITR170990597 763236RAD, FMITR170990598 763744PROT, FMITR170990599 770229XR1, FMITR170990600 770252NR1, FMITR170990601 770751PROT2, FMITR170990605 803435PROTEUS, FMITR170990606 803593ATR1, FMITR170990607 803699PR1, FMITR170990608 805278PROT, FMITR170990609 805383XR1, FMITR170990610 805497ER, FMITR170990611 805525OPXR3, FMITR170990615 810342RMC, FMITR170990616 810985PRO2, FMITR170990617 812932ORTHO, FMITR170990618 814643R1, FMITR170990619 815227OP1, FMITR170990620 817347MPTOMO, FMITR170990621 817347PRO, FMITR170990622 817545PRO, FMITR170990623 818409RAD3, FMITR170990624 818947RAD1, FMITR170990625 828315FRC, FMITR170990630 844336PROT2, FMITR170990631 847245GEXR1, FMITR170990632 847695PROTEUS1, FMITR170990634 865458RAD2, FMITR170990635 865471RAD1, FMITR170990636 865545ER2, FMITR170990637 870508BJC1, FMITR170990640 903GSPRO, FMITR170990641 904202CSRAD1, FMITR170990642 904821CHEST1, FMITR170990643 906226PRT, FMITR170990644 908522RM8WDR1, FMITR170990645 910323HSPROT1, FMITR170990646 912350TRAUMA1, FMITR170990647 912350TRAUMA2, FMITR170990648 912466PROT, FMITR170990649 912466PROT1, FMITR170990650 912691C02, FMITR170990651 913684CPRO, FMITR170990652 916781PRER1, FMITR170990653 916781PRER2, FMITR170990654 919662RAD1, FMITR170990655 919787RAD1, FMITR170990656 919787RAD2, FMITR170990657 919JMCPROT1, FMITR170990658 920327RAD, FMITR170990659 920766PR1, FMITR170990660 925210RAD1, FMITR170990661 925210RAD3, FMITR170990662 925939TR1, FMITR170990663 925939TR2, FMITR170990664 936WHERRAD, FMITR170990665 937278TRAUMA5, FMITR170990666 937278TRAUMA6, FMITR170990667 949631XR1, FMITR170990668 954987MTR1, FMITR170990669 954987MTR2, FMITR170990670 954987MTR3, FMITR170990671 970352ERRAD2, FMITR170990672 970352ERRAD3, FMITR170990673 970593XR4, FMITR170990674 979764PROT, FMITR170990675 979865PRO, FMITR170990685 AMIPROT, FMITR170990716 FCLEWPROT, FMITR170990717 FCNTTOLPROT, FMITR170990718 FHEOPROTEUS2, FMITR170990719 FHORLCHT, FMITR170990764 RADNETRAD1014, FMITR170990810 417347MWR1, FMITR170990835 317745HEPR7, FMITR170990892 210916TRM, FMITR170990893 503FCIP, FMITR170990894 520533XR3, FMITR170990895 571231RAD2, FMITR170990896 580326PRO, FMITR170990897 615563PROT, FMITR170990898 671USNPRXRA, FMITR170990899 706544HC, FMITR170990900 757889RM3, FMITR170990901 801268CHT, FMITR170990902 845938RM2, FMITR170990903 910394PROT, FMITR170990904 910907WAPROT, FMITR170990905 913682FPC1, FMITR170990906 956366RAD1, FMITR170990907 903654RAD2, FMITR170990908 952885PROT, FMITR170990911 MH693WDR1, FMITR170990912 0004077983, FMITR170990913 310374PRO, FMITR170990914 412432PROT1, FMITR170990915 732530URGF, FMITR170990916 775770RM2, FMITR170990917 940764RAD, FMITR170990918 UTPHYNEPRO, FMITR170991001 225763RAD1, FMITR170991002 252847RAD8, FMITR170991003 518254RAD2, FMITR170991004 513MWDIG1, FMITR170991005 0002920952D, FMITR170991006 0002996020, FMITR170991007 0004007896, FMITR170991008 0004024106, FMITR170991009 0004035575, FMITR170991010 0004035706, FM
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 3460
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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