Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or ...
FDA Device Recall #Z-0815-2015 — Class II — November 5, 2014
Recall Summary
| Recall Number | Z-0815-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 5, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Ultrasound, Inc. |
| Location | Bothell, WA |
| Product Type | Devices |
| 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) |
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.
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.
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.
Lot / Code Information
****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.
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| Z-1757-2024 | Class II | 5000 Compact Series Ultrasound Systems, Product... | Mar 23, 2024 |
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| Z-0284-2024 | Class II | Philips Affiniti 70, Diagnostic Ultrasound Syst... | Oct 9, 2023 |
| Z-2517-2023 | Class II | 3D9-3v Transducer, accessory to Philips Ultraso... | Jun 30, 2023 |
| Z-1380-2016 | Class II | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5... | Mar 28, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.