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.

Detalles del retiro

Fabricante

Philips Ultrasound, Inc.

Distribuidor

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.

Lote

****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, V537-152A49B

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States