Reported Dec 24, 2014 · Terminated
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed…
Philips Ultrasound, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Ultrasound, Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Additional devices
- identified in new FSN MA-FCO 83000190QLAB 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
- Lot codes and dates
- ****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.
- Amount recalled
- 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)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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