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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 110020
00000021793HL5 082407120062
00000030269HL5 082407120103
00000034231HL1 082407120118
00000030067HL3 082407140104
00000032854HL2 082407140106
00000040965HL6 082407140120
00000043163HL5 082407140124
00000029202HL9 082407150021
00000030263HL8 082407150022
00000031836HL0 082407150029
00000038943HL7 082407160198
00000045205HL2 082407160217
00000020744HL9 082407180017
00000027822HL6 082407180023
00000028270HL7 082407180024
00000028949HL6 082407180026
00000029485HL0 082407180030
00000030264HL6 082407180031
00000031843HL6 082407180033
00000034152HL9 082407180038
00000040766HL8 082407180040
00000029667HL3 082407190029
00000032856HL7 082407190034
00000032758HL5 082407190037
00000025151HL2 082407200025
00000032855HL9 082407250034
00000019516HL4 082407270052
00000019384HL7 082407270053
00000017863HL2 082407280011
00000025152HL0 082407290024
FMITR170990638 8957014379
FMITR170990848 082407010123
FMITR170990849 082407030122
FMITR170990850 082407040084
FMITR170990851 082407040105
FMITR170990852 082407040106
FMITR170990853 082407040169
FMITR170990854 082407040209
FMITR170990855 082407040250
FMITR170990856 082407040252
FMITR170990857 082407040360
FMITR170990858 082407060032
FMITR170990859 082407070048
FMITR170990860 082407070069
FMITR170990861 082407070078
FMITR170990862 082407080015
FMITR170990863 082407090088
FMITR170990864 082407100232
FMITR170990865 082407100250
FMITR170990866 082407100251
FMITR170990867 082407100370
FMITR170990868 082407140112
FMITR170990869 082407140123
FMITR170990870 082407150030
FMITR170990871 082407160082
FMITR170990872 082407160084
FMITR170990873 082407160171
FMITR170990874 082407180020
FMITR170990875 082407180034
FMITR170990876 082407270078
FMITR170990877 082407310042
FMITR170990878 082407310048
00000061109HL5 2817166XRA
00000024714HL8 73244PROTEUS
00000041097HL7 2608914PROTEUS
00000041058HL9 2625645PROT
00000036546HL0 600033RX04
00000023721HL4 CS1002RX04
00000023718HL0 CS1013RX03
00000029515HL4 CS1021RX01
00000018145HL3 CS1033RX02
00000043522HL2 CS1042RX01
00000015444HL3 CS1090RX01
00000016252HL9 CS1147RX01
00000016429HL3 CS1156RX01
00000018135HL4 CS1156RX02
00000018530HL6 CS1175RX01
00000018525HL6 CS1175RX02
00000031257HL9 CS1245RX02
00000031258HL7 CS1245RX03
00000043312HL8 CS1304RX01
00000043848HL1 CS1305RX01
00000050395HL3 CS1309RX01
00000078003HL1 CS1310RX01
00000068948HL9 CS1328RX01
00000084373HL0 CS1337RX01
00000023618HL2 CS6098RX01
FMITR170990705 CS1013RX02
FMITR170990706 CS1026RX01
FMITR170990707 CS1239RX01
FMITR170990708 CS1239RX02
FMITR170990709 CS1245RX04
FMITR170990711 DO-2792383-XR
00000053528HL6 7245PROTEUS
00000064319HL7 EG1039RX05
00000064318HL9 EG1039RX06
FMITR170990349 EG1024RX02
FMITR170990712 EE4017XR01
FMITR170990713 EE4036RX01
FMITR170990714 EE4042RX01
00000035230HL2 FI1033RX01
00000017203HL1 FI1112RX01
00000011584HL0 M1797702
00000020912HL2 M1724802
00000013443HL7 M2755001
00000031035HL9 M4162720
00000015452HL6 M4163744
00000038256HL4 M4199101
00000017251HL0 M4205408
00000035255HL9 M4207611
00000018579HL3 M4465803
00000012700HL1 M4484812
00000011070HL0 M4496931
00000029601HL2 M4501205
00000023241HL3 M5484815
00000016964HL9 M6030312
00000057206HL5 M66000402
00000017201HL5 M9196031
00000025364HL1 M9624229
00000022277HL8 M9709904
00000041634HL7 X152049203
00000013758HL8 M4170311
FMITR170990676 A1112212
FMITR170990677 A2718108
FMITR170990734 M2057406
FMITR170990735 M2734101
FMITR170990736 M4448013
FMITR170990737 M4461709
FMITR170990738 M4484983
FMITR170990739 M4499410
FMITR170990740 M9457803
FMITR170990783 U4185501
FMITR170990788 X2881409
00000021370HL2 PF1006RX02
00000020697HL9 HC0418XR06
00000011350HL6 PX1401XR01
00000057954HL0 542120XR01
00000013442HL9 CC3081XR02
00000019744HL2 CM1635XR02
00000013446HL0 HC0887XR02
00000011069HL2 HC1413XR01
00000014448HL5 HC3011XR03
00000055066HL5 HC3225XR11
00000045515HL4 HC3295XR02
00000045537HL8 HC3295XR03
000
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
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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