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.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

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.

Lote

Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO 00000018576HL9 850747GCER 00000024536HL5 904391RAD1 00000019171HL8 561395RAD 00000020749HL8 773282TOMO8 00000034015HL8 847316PROER1 00000012567HL4 502868RAD2 00000017199HL1 972596OPRAD1 00000017648HL7 405271UPX1 00000032656HL1 407518PR1 00000041533HL1 580249SPRO2 00000022569HL8 614868PRO4 00000012718HL3 706257SFP 00000020559HL1 770748PER 00000033658HL6 704783PRO1 00000019846HL5 423493ER 00000031607HL5 605342RAD 00000012703HL5 915573RAD1 00000012705HL0 915573RAD2 00000020034HL5 410392R3 00000022299HL2 706554MSR1 00000003188HL2 901722RAD1 00000019209HL6 718780RAD1 00000011073HL4 865425RAD2 00000018254HL3 281338RAD 00000020919HL7 801292RM3 00000041379HL9 580249SPRO 00000038277HL0 408885SVC 00000029264HL9 561863RM6 00000038416HL4 702382XR1 00000030772HL8 201291PROTEUS 00000018574HL4 201358ER1 00000018682HL5 201358ER2 00000023348HL6 201418RAD1 00000021851HL1 201418RAD3 00000030395HL8 201599PRO 00000100468HL8 201795ER 00000032859HL1 202269PRO 00000013889HL1 202715PRO 00000016974HL8 203679RAD 00000078697HL0 203688PROTLW2 00000021322HL3 203797PROT1 00000022725HL6 203797PROT2 00000028953HL8 203797PROT3 00000027089HL2 203852ED1 00000030390HL9 203852RM1 00000028277HL2 203852RM5 00000023570HL5 205387PRO 00000044402HL6 205750RAD 00000013259HL7 206215RM1 00000037711HL9 206248RAD1 00000034679HL1 206302XRM1 00000013114HL4 206543HECED 00000016238HL8 207454CRAD1 00000080456HL7 207664PROTEUS 00000039888HL3 207795CM3 00000018794HL8 208227RM1 00000019521HL4 208227RM5 00000040501HL9 208265PROT 00000020176HL4 208359RM2 00000020667HL2 208373RAD2 00000023516HL8 208373RAD3 00000019212HL0 208381ED1 00000103408HL1 208402RAD1 00000042856HL5 208455RAD3 00000041973HL9 208455RAD4 00000035259HL1 208463RAD1 00000015447HL6 208463RAD2 00000029208HL6 208476CRAD 00000037477HL7 208524ROOM2 00000013648HL1 208529ER 00000038278HL8 208667KS 00000029103HL9 208746VX1A 00000017660HL2 208756SX2 00000014152HL3 208785RAD 00000014711HL6 208882GX1A 00000010593HL2 208893RAD2 00000024418HL6 208983SRAD 00000043582HL6 209223PROTAM1 00000023095HL3 209385RAD1 00000024355HL0 209524GR5 00000022811HL4 209577RAD3 00000047950HL1 209578ER1 00000059852HL4 209664RAD3 00000043977HL8 209754RAD1 00000029481HL9 209832RAD1 00000047492HL4 209835RAD2 00000020668HL0 209848OVRAD2 00000014446HL9 209943SJRM2 00000029151HL8 210297BMCR5 00000039510HL3 210297NCER1 00000025154HL6 210297NCRAD 00000025532HL3 210297NERAD 00000029153HL4 210297SEBR4 00000046415HL6 210575LCRAD 00000045916HL4 210590OWRAD 00000031131HL6 210614PRO 00000032826HL0 210614SPRO 00000029511HL3 210616MCTRAD2 00000041870HL7 210616PRO 00000029671HL5 210616R2 00000044731HL8 210617NEI1 00000029265HL6 210646NEMR1 00000037581HL6 210646RAD2 00000016636HL3 210704SRER 00000032255HL2 210705MCER 00000042165HL1 210921PRO 00000023092HL0 212241RAD 00000041980HL4 212312PRO1 00000042075HL2 212312PRO2 00000019847HL3 212570RAD 00000021798HL4 212604PROT1 00000021682HL0 212604PROT3 00000019515HL6 213744PROTXR2 00000070214HL2 214266IRVPRO 00000036459HL6 214266RAD1 00000013453HL6 214320PROT2 00000016419HL4 214320PTOMO 00000031876HL6 214345RAD1 00000094194HL8 214491RPG 00000036568HL4 215441PROT1 00000024635HL5 215453PRO3 00000043808HL5 215481PROT1 00000014447HL7 215918RAD1 00000014709HL0 215918RAD2 00000016795HL7 215952PROT 00000043807HL7 215955PROER 00000045769HL7 215955PROER2 00000014147HL3 216343R3 00000014298HL4 216343R4 00000020177HL2 216363RAD 00000044378HL8 216363RAD1 00000047424HL7 216778RAD1 00000036104HL8 216844PRO1 00000024694HL2 217222QR6 00000012561HL7 217258SR3 00000024632HL2 217333LXR2 00000037884HL4 217333MXR1 00000028272HL3 217337CXR3 00000081388HL1 217366CWXR2 000000

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States