Device Recall QLAB Quantification Software

  • 모델명 / 제조번호(시리얼번호)
    ****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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • 제조사 모회사 (2017)
  • Source
    USFDA