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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 Posted July 02, 2014
Recall Status1 Terminated 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 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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