GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2 Product Usage: Advantage Workstation version 4.2: The Advantage Workstation 4.2 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis. Advantage Workstation version 4.3/4.4 : The Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality DIACOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images of the AW monitor may be used as a basis for diagnosis, except in the case of mammography.
Publicado el 22 de agosto de 2012 · Inicio del retiro: 24 de mayo de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET serie
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- Worldwide Distribution - US (nationwide) including the states of : AL, AZ, AR, CA, CO, DE, DC, FL, GA, GU, HI, IK, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO,MT, NE,NH,NJ, NM, NY, NC, ND, OH, OK, PA, PR, SC, SD, TN, TX, VA, WA, WV, WI and the countries of YUGOSLAVIA, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SA¿DE ARABIA, RUSSIAN FEDERATION, ROMANIA, REPUBLIC OF MALTA, PORTUGAL, POLAND, PHILIPPINES, NORWAY, NIGERIA, NEW ZEALAND, MEXICO, KOREA, KENYA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, HUNGRY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
- Lote
- FMI 25404 Additional Consignees Mfg Lot or Serial # System ID (As required) 00000020D6C6F IE1085AW02 00000029FDB24 A4194418 0000002A8C1D3 ws132201 0000002AB15AF PL1008AW03 00000L0201354A RJ0005 00000L02013776 HC9074AW01 00000L02013900 00137ADW03 00000L020140F4 10146ADW01 00000L02014128 PPR83607 00000L02014228 082421060040AW 00000L0201485E 813642AW42 00000L0201492C 864366AAW 00000L020149E4 083055065231713 00000L02014C1C 2526577 00000L0201521E 26329AW2 00000L02019460 617355AW3 00000L020194E0 919660AWMRI 00000L020195D0 352CDCAW43 00000L02019690 809780AW2 00000L02019696 510295ANAW 00000L020197FE 2535997AW42 00000L020198A8 WS98556 00000L02019944 706774AW2 00000L02019946 716887AW2 00000L0201994E 716887AW1 00000L02019A02 EG1277AW01 00000L02019ABA 617355AWPC1 00000L02019AE8 850475PAW 00000L0202AC34 082416310006AW 00000L0202AEB4 600160AW01 00000L0202AECA 083055822100526 00000L0202B4AA CC4400AW03 00000L0202B4B8 083049062634502 00000L0202B4BF 083049802101529 00000L0202B4C2 0920559053AW1 00000L0202B4D2 B5298307 00000L0202B52F TN1270AW01 00000L0202B53F TN1273AW01 00000L0202B5BA 900010AW20 00000L0202B639 00860ADW04 00000L0202B668 082421190132AW 00000L0202B677 0910553081AW1 00000L0202B678 082421100352AW 00000L0202B6AE A5251313 00000L0202B773 DPB15840 00000L0202B774 082416040018AW 00000L0202B786 EE672841 00000L0202B7D6 X185801202 00000L0202B7D9 RU1106AW04 00000L0202B7EC 083049202100256 00000L0202B7EE 0853550270 00000L0202B82F RU1834AW01 00000L0202B834 0850270206AW1 00000L0202B84F 00010DCS01 00000L02065AA0 WS98553 00000L02065C50 200ADW42 00000L02068382 470240AW01 00000L0206A4C6 517353MAMAW 00000L0206AC90 850494WSPAW 00000L0207263E 361595SKW1 00000L02072650 419251CTA 00000L020727D2 786AW1BAY 00000L02072ADE RADNETWS1007 00000L02072B8A WCATHWS41 00000L02072B96 973972AWW3 00000L02072B98 515424PC1 00000L02072D02 58831121222 00000L02072D58 916454AW42 00000L02072E4E 3454AWW 00000L020730A2 973972AWW4 00000L020730C8 317621ICAW43 00000L02078D4B 724230AW1 00000L020B0B01 847360AW2 00000L020B0B08 SA2087AW01 00000L020B0B1A 083049842100056 00000L020B0B36 928753AWDR 00000L020B0B3C 514842AAW6 00000L020B0B79 DZ1193AW01 00000L020B0C2F 973877AWW1 00000L020B0D3D 623848SPAW 00000L020B3561 AH5689AW01 00000L020B3582 082416040019AW 00000L020B3590 AH5689AW02 00000L020B35D8 0910552207 00000L020B55FE 281364NUAW 00000L020CFA66 7137764100AW 00000L020CFAE5 41018DCS01 00000L020D4CD9 EE1019AW05 00000L020D4E25 M4174713 00000L020D61F7 B5112508 00000L020D637D RU1595AW01 00000L020D6385 FEG85408 00000L020D644C IE1105AW02 00000L020D6664 SA1005AW01 00000L020D668B HC2821AW02 00000L020D66F2 B5603920 00000L020D6757 082427150027AW 00000L020D6759 091553022AW1 00000L020D67F4 DZ1004AW02 00000L020D69C0 0853550299 00000L020D69D8 00200ADW05 00000L020D69FB M2364523 00000L020D6C7B 0850210588AW1 00000L020D6D52 M117934002 00000L020D6D76 0850060726AW1 00000L020D6DBF 082427130031AW 00000L020D6DE1 EPP04110 00000L020D6DE9 RU1195AW02 00000L020D6E5B BG4549AW02 00000L020D6F6B EG1549AW01 00000L020D6FAB 082427120049AW 00000L020D71B9 IE1087AW01 00000L020D72E7 RU1195AW04 00000L020D750A RU2342AW01 00000L020D76DF UK1102AW02 00000L020D7722 PZ0126 00000L020D7728 BY4015AW01 00000L020D77EC 082427100073AW 00000L020D78BA M9164770 00000L020D78C5 1221242AWW 00000L020D79A9 083049802100616 00000L020D7AAE 083055282100776 00000L020DAF12 09004DCS01 00000L020DB02D 082416130025AW 00000L020DB06D 323442MR3AW 00000L020DB144 M9886835 00000L020DB1DE 225246BRCAW 00000L020DB1EB 323441AWMR 00000L020DB21A M54606107 00000L020DB2E2 PZ0251 00000L020DB2FD 06052DCS03 00000L020DB2FE PL1530AW01 00000L020DB332 PPR59033 00000L020DB335 H2036ADW27 00000L020DB396 A5196333 00000L020DB397 BG4549AW04 00000L020DB49D 082427100074AW 00000L020DB49F NO1011AW14 00000L020DB4AC RU1457AW01 00000L020DB4CE PZ0364 00000L020DB5F2 X147408504 00000L020DB607 317887PVAW 00000L020DB612 708383MRAW 00000L020DB6A0 5618
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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