Additional devices identified in new FSN MA-FCO recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

****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.

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.…

Recalling firm

Philips Ultrasound, Inc.

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.

Recall date

December 24, 2014

Classification

Class II

Status

Terminated

Agency

FDA (device)