Philips Ultrasound, Inc.: 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.

Recall number

Z-0815-2015

Recalling firm

Philips Ultrasound, Inc.

Product

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.

Status

Terminated

Initiated

2014-11-05

Posted

2014-12-16

Terminated

2016-08-15

Reason

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.

Root cause

Software design

Action

Philips has identified additional affected units and sent the Urgent-Field Safety Notice -Philips Ultrasound QLAB 10.0 (on Xcelera) letter, dated 2015/3/17, to their consignees. The FCO associated with this letter is FSN MA-FCO 83000190. The affected units identified as QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. QLAB software installed on Philips diagnostic ultrasound systems (carts) is the subject of a separate Field Safety Notice (FSN MA-FCO79500316 ). Philips has corrected this issue with QLAB version 10.2 on Xcelera and will contact customers to arrange installation of the upgrade to version 10.2 or higher free of charge. If consignees need any further information or support concerning the FCO 83000190, please contact your local Philips representative or Philips Customer Service at 1-800-722-9377. *************************************************************************************** Philips has begun sending out the URGENT - Medical Device Correction letters, dated 2014 NOV 05, for the Philips Ultrasound QLAB, Philips Model EPIQ 5 Ultrasound System, Philips Model EPIQ 7 Ultrasound System, and Philips Ultrasound Q-Station. The customer letter is also identified with the FSN # 79500316; 79500317; 79500318; or 79500321. The letters notified customers that Erroneous End-Systolic Volumes and Ejection Fraction May Be Reported When Using a2DQ & aCMQ (Auto 2D Quantification & Auto Cardiac Motion Quantification). Customers with questions should contact local Philips representative or Philips Customer Service at 1-866-767-7822.

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)

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.

Lot, serial or model codes

****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.

510(k) numbers

["K132165"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

3019216

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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