Philips Ultrasound, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0815-2015)

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.

Class II

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.

****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.

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.

Voluntary: Firm initiated