Device Recall QLAB Quantification Software

  • Modèle / numéro de série
    ****Additional 52 international units were discovered and added to FCO 79500316**  14D4-N1E2F306-W3BC, 15D5-14041EA3-27F8, 1788-H1DD736A-I3B1,  20B6-13C298A0-2775, 236A-13BD1904-276A, 28C1-13DDA15F-27AB,  3391-13C7A2EF-277F, 3BAD-13B7241B-275E, 4549-N20290C7-G3FB,  464A-1423BC64-2837, 466C-13CCAD3E-2789, 5019-S1EC9257-K3CF,  5581-V1E1931F-U3B9, 5BD9-14234717-2836, 6676-148FDF60-290F,  685C-H1E69D6E-W3C3, 6B10-Q1E11DD2-U3B8, 6C00-142DD102-284B,  7168-1422D1CA-2835, 741C-141D522E-282A, 75CF-J1F6A6F5-M3E3,  7E75-1538H8C3-2A5F, 7EFD-13DBCC2B-27A7, 8719-13CB4D57-2786,  8945-1522HA53-2A33, 8F13-1411DDA9-2813, 937A-P1E5B2D4-K3C1,  9448-1489752A-2902, 972F-14015ED5-27F2, 99E3-13FBDF39-27E7,  9B85-R200BB93-H3F7, 9C97-13F65F9D-27DC, B4C9-141BF247-2827,  B65A-P24C5634-R48E, C14C-K1DF489E-I3B4, C25E-13D4ECA8-2799,  C7C6-13C9ED70-2783, CC0B-K1F4D1C1-N3DF, D285-13DF7693-27AE,  D539-13D9F6F7-27A3, D7CB-142B8681-2846, DFD6-14468F40-287C,  E2BD-13BE78EB-276C, E571-13B8F94F-2761, E9B6-Y1E3DDA0-Q3BD,  EC6A-S1DE5E04-V3B2, F2D3-13F48A69-27D8, FABC-1466A24E-28BC,  FF12-M265FF0C-G4C1, FF45-S1E36853-Q3BC, M1F9-V1DDE8B7-M3B2, and P873-13C88D89-2781.   **ADDITIONAL SYSTEM CODES FOR 261 UNITS UNDER FCO 83000190******  830038; 830069; 830353; 830255  ********************************************************************************************  SERIAL NUMBERS FOR INTERNATIONAL UNITS   1580-14DDC482-29AB, 15A2-1486B55C-28FD, 1777-H208FAFD-P408,  1A2B-T2037B61-I3FD, 1AC6-1529D470-2A43, 1AF9-14A73DB7-293E,  1B3D-13F91F6B-27E2, 2050-14C7C612-297F, 2225-Q24APBB3-K48A,  2326-146B3750-28C6, 25FC-140EA88E-280D, 286C-14B7473E-295E,  2B0F-14DD4F35-29AA, 2B20-14B1C7A2-2953, 2DD4-14AC4806-2948,  2DE5-1480C073-28F1, 2FBA-N203P614-J3FC, 3055-15295F23-2A42,  3088-14A6C86A-293D, 30AA-144FB944-288F, 30CC-13F8AA1E-27E1,  3380-13F32A82-27D6, 3500-S24F1602-P494, 3893-14C1D129-2973,  3B25-151360B3-2A16, 3DFB-14B6D1F1-295D, 409E-14DCD9E8-29A9,  4330-152E6972-2A4C, 4374-14804B26-28F0, 45E4-1528E9D6-2A41,  4617-14A6531D-293C, 4639-144F43F7-288E, 48CB-14A0D381-2931,  48ED-1449C45B-2883, 4AB1-I1F7918F-K3E5, 4B6E-14C6DB78-297D,  4D65-G1F211F3-R3DA, 4E77-13E7B5FD-27BF, 513C-13B6AECE-275D,  538A-14B65CA4-295C, 5903-147FD5D9-28EF, 5AD8-H2021B7A-P3FA,  5BEA-13F7BF84-27DF, 5E9E-13F23FE8-27D4, 60FD-14C6662B-297C,  6130-1443CF72-2877, 62F4-Y1F19CA6-J3D9, 63D3-1469D769-28C3,  6406-13E740B0-27BE, 68E6-15387E10-2A60, 6AFF-V20CA565-U40F,  6B9A-1532FE74-2A55, 6E70-14D66FB2-299C, 6EC5-13FCC9D3-27E9,  7135-14A56883-293A, 718A-13CBC2A4-2787, 76AE-146EE1B8-28CD,  7861-S248367F-S486, 7940-14C07142-2970, 7984-141252F6-2814,  7995-13E6CB63-27BD, 7C27-14385AED-2860, 7EEC-140753BE-27FE,  814B-14DB7A01-29A6, 8342-H206B07C-X403, 8410-14AA72D2-2944,  8421-147EEB3F-28ED, 8454-13FC5486-27E8, 8691-152789EF-2A3E,  86C4-14A4F336-2939, 8C70-13EBD5B2-27C7, 8C81-13C04E1F-2770,  8EAD-1517YB1B-2A1D, 91A5-14636D33-28B6, 9404-15379376-2A5E,  947B-1406DE71-27FD, 9C20-152714A2-2A3D, A4B3-13E5E0C9-27BB,  A9C6-14B48770-2958, A9F9-1431F0B7-2853, AEFB-152C1EF1-2A47,  AF2E-14A98838-2942, AF50-14527912-2894, B1E2-14A4H89C-2937,  B496-149E8900-292C, B77D-141672AB-281C, B930-G1EFC772-R3D5,  B9ED-14BF115B-296D, BA42-13E56B7C-27BA, C1D6-15312940-2A51,  C1F8-14DA1A1A-29A3, C209-14AE9287-294C, CA25-149E13B3-292B,  CA36-14728C20-28D4, CF7C-14BE9C0E-296C, D230-14B91C72-2961,  D252-1462VD4C-28B3, D4D3-14DF2469-29AD, D6B9-U235E277-N461,  D6CA-R20A5AE4-M40A, D787-14D9A4CD-29A2, D97E-V204DB48-S3FF,  DA19-152B3457-2A45, DA90-13FA7F52-27E4, DD00-14A31E02-2935,  DD22-144CNEDC-2887, DEE6-R1F9DC10-J3E9, DF81-1520351F-2A2F,  E44E-M1EEDCD8-M3D3, E53E-143B9008-2866, EA62-14DEAF1C-29AC,  EA73-14B32789-2955, EA84-14879FF6-28FE, EFEC-147CA0BE-28E8,  EFFD-1451192B-2891, F01F-13FAQA05-27E3, F510-151FBFD2-2A2E,  F707-U24AF64D-S48B, F82A-141512C4-2819, FAEF-13E4KB95-27B7,  G5AE-13F994B8-27E3, KG13-14872AA9-28FE, PD75-14C2BBC3-2975,  R2A5-14D8BA33-29A1, S81E-14A23368-2934, V537-152A49BD-2A44,  Y2D8-1456237A-289C, and YC96-H24A8100-S48B.   *********************************************************************************************  SERIAL NUMBERS FOR UNITS IN THE US FOR FCO 79500316 1007-15144B4D-2A18, 1029-14BD3C27-296A, 103A-1491B494-2913,  105C-143AA56E-2865, 12AA-153A5344-2A64, 12CC-14E3441E-29B6,  12FF-1460AD65-28B1, 1332-13DE16AC-27AC, 14A1-U26589BF-Q4C1,  1591-14B23CEF-2954, 15B3-145B2DC9-28A6, 15C4-142FA636-284F,  1812-152F540C-2A4E, 1834-14D844E6-29A0, 1845-14ACBD53-2949,  1856-148135C0-28F2, 1867-1455AE2D-289B, 1878-142A269A-2844,  1B1B-14502E91-2890, 1DAD-14A1BE1B-2933, 1DBE-14763688-28DC,  1DCF-144AAEF5-2885, 1DE0-141F2762-282E, 1E02-13C8183C-2780,  1F71-I24F8B4F-X495, 2083-14452F59-287A, 2247-Q1F2FC8D-H3DC,  2304-14C24676-2974, 2315-1496BEE3-291D, 2337-143FAFBD-286F,  2348-1414282A-2818, 24D9-J2448C17-Q47F, 25B8-14BCC6DA-2969,  25C9-14913F47-2912, 260D-13E320FB-27B6, 261E-13B79968-275F,  285B-14E2CED1-29B5, 287D-148BBFAB-2907, 288E-14603818-28B0,  28B0-140928F2-2802, 2A30-J2651472-Y4C0, 2B53-142F30E9-284E,  2B64-1403A956-27F7, 2B75-13D821C3-27A0, 2DC3-14D7CF99-299F,  2DF6-145538E0-289A, 2E07-1429B14D-2843, 2E18-13FE29BA-27EC,  332B-14CCD061-2989, 334D-1475C13B-28DB, 335E-144A39A8-2884,  35DF-14C750C5-297E, 35F0-149BC932-2927, 37B4-J2499666-K489,  37D6-Y1F28740-S3DB, 38A4-14964996-291C, 38B5-146AC203-28C5,  38E8-13E82B4A-27C0, 38F9-13BCA3B7-2769, 3B47-14BC518D-2968,  3B69-14654267-28BA, 3D2D-N213HF9B-J41C, 40AF-14B15255-2952,  40D1-145A432F-28A4, 40F3-14033409-27F6, 4352-14D75A4C-299E,  4363-14ABD2B9-2947, 4385-1454C393-2899, 43A7-13FDB46D-27EB,  4606-14D1DAB0-2993, 4628-147ACB8A-28E5, 48BA-14CC5B14-2988,  48DC-14754BEE-28DA, 48FE-141E3CC8-282C, 4920-13C72DA2-277E,  4B90-146FCC52-28CF, 4BA1-144444BF-2878, 4D43-K2492119-P488,  4E22-14C15BDC-2972, 4E33-1495D449-291B, 4E44-146A4CB6-28C4,  4E55-143EC523-286D, 4E66-14133D90-2816, 50D6-14BBDC40-2967,  50F8-1464CD1A-28B9, 5109-14394587-2862, 511A-140DBDF4-280B,  52BC-X2129A4E-N41B, 5379-14E1E437-29B3, 562D-14DC649B-29A8,  563E-14B0DD08-2951, 5693-13D73729-279E, 58F2-14AB5D6C-2946,  5947-13D1B78D-2793, 5B95-14D16563-2992, 5BA6-14A5DDD0-293B,  5BB7-147A563D-28E4, 5BC8-144ECEAA-288D, 5BFB-13CC37F1-2788,  5E49-14CBE5C7-2987, 5E7C-14494F0E-2882, 601E-P24E2B68-J492,  610E-149ADE98-2925, 6152-13ECC04C-27C9, 62D2-I248ABCC-X487,  63C2-14955EFC-291A, 6665-14BB66F3-2966, 6687-146457CD-28B8,  6698-1438D03A-2861, 66BA-13E1C114-27B3, 6908-14E16EEA-29B2,  693B-145ED831-28AD, 694C-1433509E-2856, 695D-1407C90B-27FF,  6AEE-K2382CF8-X466, 6BBC-14DBEF4E-29A7, 6E81-14AAE81F-2945,  6E92-147F608C-28EE, 6EA3-1453D8F9-2897, 7067-W201A62D-Q3F9,  7146-1479E0F0-28E3, 7157-144E595D-288C, 73D8-14CB707A-2986,  73FA-14746154-28D8, 740B-1448D9C1-2881, 766A-151DYWX4-2A29,  7962-1469621C-28C2, 7973-143DDA89-286B, 7BD2-1512UICC-2A13,  7E97-14E0F99D-29B1, 7EB9-1489EA77-2903, 7ECA-145E62E4-28AC,  7EDB-1432DB51-2855, 807D-G237B7AB-H465, 815C-14AFF26E-294F,  816D-14846ADB-28F8, 81A0-1401D422-27F3, 81B1-13D64C8F-279C,  8432-145363AC-2896, 86B3-14D07AC9-2990, 86D5-14796BA3-28E2,  8967-14CAFB2D-2985, 8978-149F739A-292E, 8989-1473EC07-28D7,  89CD-13C5CDBB-277B, 8B5E-N1F631A8-H3E2, 8C1B-14C57B91-297A,  8C2C-1499F3FE-2923, 8C3D-146E6C6B-28CC, 8E12-G1F0B20C-W3D7,  8EE0-14947462-2918, 8F02-143D653C-286A, 8F24-13E65616-27BC,  9183-14BA7C59-2964, 91C7-140C5E0D-2808, 9426-14E08450-29B0,  9437-14B4FCBD-2959, 9459-145DED97-28AB, 946A-14326604-2854,  96DA-14DBH4B4-29A5, 96EB-14AF7D21-294E, 998E-14D58518-299A,  99B0-147E75F2-28EC, 99C1-1452EE5F-2895, 9C75-144D6EC3-288A,  9C86-1421E730-2833, 9CA8-13CAD80A-2785, 9E39-U1FB3BF7-N3EC,  9EF6-14CA85E0-2984, 9F07-149EFE4D-292D, 9F18-147376BA-28D6,  9F29-1447EF27-287F, A1BB-14997EB1-2922, A1CC-146DF71E-28CB,  A45E-14BF86A8-296E, A491-143CEFEF-2869, A4A2-1411685C-2812, A 712-14BAI70C-2963, A723-148E7F79-290C, A734-1462F7E6-28B5, A745-14377053-285E, A993-15371E29-2A5D, A9B5-14E0TF03-29AF,  A9E8-145D784A-28AA, AA0A-14066924-27FC, AC69-14DA8F67-29A4,  ACCF-13D561F5-279A, AF1D-14D5YFCB-2999, AF3F-147EPYA5-28EB,  AF72-13FB69EC-27E6, B1D1-14CF902F-298E, B1F3-14788109-28E0,  B3C8-W1FAC6AA-J3EB, B485-14CA1093-2983, B4A7-1473P16D-28D5,  B739-14C490F7-2978, B75B-146D81D1-28CA, B78E-13EAEB18-27C5,  BA20-143C7AA2-2868, BCA1-14B991BF-2962, BCC3-14628299-28B4,  BCD4-1436FB06-285D, BF22-1536A8DC-2A5C, BF44-14DF99B6-29AE,  BF55-14B41223-2957, BF77-145DQ2FD-28A9, BF88-14317B6A-2852,  C22B-14578361-289E, C23C-142BFBCE-2847, C24D-1400743B-27F0,  C3DE-G230D828-M457, C4DF-1452W3C5-2893, C73E-15262A08-2A3B,  C760-14CF1AE2-298D, C782-1478NBBC-28DF, C7A4-1420FC96-2831,  C957-X1FA515D-R3EA, C9F2-1520AA6C-2A30, CA14-14C99B46-2982,  CCEA-146DSC84-28C9, CEBF-S1EF5225-G3D4, CF9E-14678CE8-28BE,  CFC0-14107DC2-2810, CFE2-13B96E9C-2762, D241-148D94DF-290A,  D263-143685B9-285C, D4E4-14B39CD6-2956, D4F5-14881543-28FF,  D506-145C8DB0-28A8, D517-1431Q61D-2851, D528-14057E8A-27FA,  D7BA-1457HE14-289D, D96D-R23062DB-X456, DA4C-14A89D9E-2940,  DA6E-14518E78-2892, DCEF-14CEA595-298C, DD11-1477966F-28DE,  DFA3-14C925F9-2981, E009-13C3F887-2777, E178-X24B6B9A-V48C,  E279-146C9737-28C8, E28A-1441RFA4-2871, E4E9-151535E7-2A19,  E50B-14BE26C1-296B, E54F-1410X875-280F, E7E1-146197FF-28B2,  E7F2-1436106C-285B, EAA6-143090D0-2850, EAB7-1405Y93D-27F9,  EAC8-13D981AA-27A2, ED16-14D92F80-29A1, ED27-14ADA7ED-294A,  ED49-145698C7-289C, ED5A-142B1134-2845, ED6B-13FF89A1-27EE,  EFCA-14D3AFE4-2996, F00E-14259198-283A, F030-13CE8272-278C,  F1C1-P1FEE65F-H3F3, F27E-14CE3048-298B, F2A0-14772122-28DD,  F2B1-144B998F-2886, F2E4-13C9S2D6-2781, F532-14C8B0AC-2980,  F543-149D2919-2929, F7E6-14C33110-2975, F808-146C21EA-28C7,  FAAB-149229E1-2913, FACD-143B1ABB-2865, FB00-13B88402-2760,  FD4E-14B831D8-295F, FD5F-148CAA45-2908, FD70-146122B2-28B1,  FD81-14359B1F-285A, FFF1-14DE39CF-29AB, HV24-145BA316-28A7,  J283-152FC959-2A4F, JDCA-13E915E4-27C2, M559-14D33A97-2996,  M58C-1450A3DE-2891, M82F-1476ABD5-28DD, MD97-146BAC9D-28C7,  NDA8-1440250A-2870, NM46-140493F0-27F9, R1D7-M234F7DD-R460,  SAE3-14712C39-28D2, U2B6-14AD32A0-294A, UB27-13C3NDED-2776,  VF4A-T245V164-S480.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution (for FCO 83000190): US, including the states of AK, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, and WI; and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Germany, Ecuador, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, Norway, New Zealand, Philippines, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, and Vietnam. ********************************************************************************** Worldwide Distribution -- US, including the states of KY, TN, ME, CA, PA, NC, CT, NY, SC, IL, IN, and WI; and the countries of Argentina, Spain, India, Italy, Austria, Germany, Belgium, Canada, Finland, Switzerland, Greece, Malaysia, Sweden, Australia, Netherlands, Mexico, Peru, Taiwan, Japan, France, and Norway.
  • Description du dispositif
    Additional devices identified in new FSN MA-FCO 83000190: || QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips || Xcelera software. || *********************************************************************************** || Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) || QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 || Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Société-mère du fabricant (2017)
  • Source
    USFDA