{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bothell",
      "state": "WA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69790",
      "recalling_firm": "Philips Ultrasound, Inc.",
      "address_1": "22100 Bothell Everett Hwy",
      "address_2": "N/A",
      "postal_code": "98021-8431",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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.",
      "recall_number": "Z-0815-2015",
      "product_description": "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.",
      "product_quantity": "additional 52 international units; 261 units (73 in the US and 188 outside the US); 417 units (289 in the US and 128 outside US)",
      "reason_for_recall": "When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB.  An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy.",
      "recall_initiation_date": "20141105",
      "center_classification_date": "20141216",
      "termination_date": "20160815",
      "report_date": "20141224",
      "code_info": "****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."
    }
  ]
}