Philips Ultrasound, Inc.

13 devices in the database

  • Model / Serial
    SERIAL NUMBERS FOR FCO 79500321- Q-Station Quantification Software SYSTEM:  16B7-KADBT53D-15A9, 196B-UAD585A1-159E, 1ED3-QACA8669-1588,  2187-VAC5T6CD-157D, 2C46-QADA8FF0-15A8, 2EFA-RAD51054-159D,  3716-IAC49180-157C, 41D5-NADA1AA3-15A7, 4489-SAD49B07-159C, 49F1-IAC99BCF-1586, 4CA5-UAC41C33-157B, 5764-MAD9A556-15A6, 5A18-QAD425BA-159B, 5CCC-HACEA61E-1590, 5F80-MAC92682-1585, 6CF3-WAD93009-15A5, 725B-GACE30D1-158F, 750F-TAC8B135-1584, 8282-JAD8BABC-15A4, 8536-IAD33B20-1599, 87EA-PACDBB84-158E, 8A9E-RAC83BE8-1583, 9811-WAD8456F-15A3, 9D79-WACD4637-158D, AAEC-MADD4FBE-15AD, ADA0-PAD7D022-15A2, B054-UAD25086-1597, B308-JACCD0EA-158C, B5BC-RAC7514E-1581, C07B-KADCDA71-15AC, C897-TACC5B9D-158B, D60A-GADC6524-15AB, D8BE-KAD6E588-15A0, DB72-RAD165EC-1595, DE26-WACBE650-158A, E0DA-XAC666B4-157F, EE4D-IAD6703B-159F, F3B5-IACB7103-1589, F669-PAC5F167-157E, H944-VACAFBB6-1589, MBF8-WAC57C1A-157E, T3DC-SAD5FAEE-159F, and Y690-GAD07B52-1594.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. || Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
  • Model / Serial
    SERIAL NUMBERS FOR FCO 079500318- EPIQ 7 SYSTEM:  US114B0038, US114B0040, US114B0055, US114B0091, US114B0111, US114B0112, US114B0113, US114B0114, US114B0115, US114B0125, US114B0128, US114B0129, US114B0161, US114B0185, US114B0186, US114B0201, US114B0204, US114B0225, US114B0235, US114B0236, US114B0266, US114B0267, US114B0307, US114B0335, US114B0336, US114B0337, US114B0355, US114B0358, US114B0359, US114B0360, US114B0398, US114B0399, US114B0400, US114B0401, US114B0471, US114B0473, US114B0474, US114B0478, US114B0493, US114B0494, US114B0495, US114B0508, US114B0510, US114B0511, US114B0527, US114B0528, US114B0529, US114B0530, US114B0572, US114B0579, US114B0580, US114B0581, US114B0582, US114B0596, US114B0599, US114B0600, US114B0601, US114B0602, US114B0603, US114B0604, US114B0608, US114B0615, US114B0620, US114B0621, US114B0622, US114B0650, US114B0651, US114B0657, US114B0658, US114B0668, US114B0694, US114B0700, US114B0745, US114B0747, US214B0003, US214B0004, US214B0038, US214B0039, US214B0080, US214B0097, US214B0137, US214B0146, US214B0164, US214B0165, US214B0175, US214B0191, US214B0194, US214B0199, US214B0243, US214B0247, US214B0248, US214B0249, US214B0396, US214B0397, US214B0399, US214B0400, US214B0402, US214B0403, US214B0404, US214B0431, US214B0432, US214B0433, US214B0435, US214B0436, US214B0437, US214B0438, US214B0439, US214B0445, US214B0446, US214B0447, US214B0448, US214B0461, US214B0462, US214B0463, US214B0464, US214B0468, US214B0470, US214B0471, US214B0474, US214B0519, US214B0520, US214B0521, US214B0522, US214B0525, US214B0529, US214B0530, US214B0551, US214B0568, US214B0569, US214B0571, US214B0572, US214B0573, US214B0578, US314B0014, US314B0016, US314B0062, US314B0063, US314B0065, US314B0066, US314B0095, US314B0096, US314B0098, US314B0174, US314B0175, US314B0220, US314B0221, US314B0222, US314B0223, US314B0224, US314B0225, US314B0226, US314B0227, US314B0228, US314B0229, US314B0239, US314B0267, US314B0268, US314B0272, US314B0273, US314B0274, US314B0275, US314B0276, US314B0277, US314B0278, US314B0279, US314B0280, US314B0281, US314B0301, US314B0302, US314B0303, US314B0304, US314B0308, US314B0309, US314B0310, US314B0311, US314B0312, US314B0313, US314B0314, US314B0315, US314B0316, US314B0317, US314B0318, US314B0320, US314B0340, US314B0341, US314B0342, US314B0343, US314B0344, US314B0345, US314B0346, US314B0347, US314B0348, US314B0349, US314B0350, US314B0351, US314B0352, US314B0353, US314B0354, US314B0355, US314B0356, US314B0357, US314B0379, US314B0380, US314B0381, US314B0382, US314B0383, US314B0384, US314B0385, US314B0386, US314B0387, US314B0388, US314B0389, US314B0390, US314B0391, US314B0392, US314B0396, US314B0406, US314B0407, US314B0408, US314B0409, US314B0410, US314B0411, US314B0412, US314B0413, US314B0414, US314B0422, US314B0448, US314B0449, US314B0450, US314B0451, US314B0452, US314B0453, US314B0454, US314B0455, US314B0456, US314B0457, US314B0458, US314B0459, US314B0460, US314B0461, US314B0487, US314B0495, US314B0496, US314B0497, US314B0498, US314B0499, US314B0500, US314B0501, US314B0502, US314B0545, US314B0546, US314B0547, US314B0548, US314B0549, US314B0550, US314B0551, US314B0552, US314B0553, US314B0554, US314B0555, US314B0556, US314B0615, US314B0616, US314B0617, US314B0618, US314B0619, US314B0620, US314B0621, US314B0622, US314B0623, US314B0624, US314B0625, US314B0626, US314B0627, US314B0628, US314B0629, US314B0630, US314B0631, US314B0684, US314B0685, US314B0686, US314B0687, US314B0688, US314B0689, US314B0690, US314B0691, US314B0692, US314B0693, US314B0694, US314B0695, US314B0696, US314B0697, US314B0698, US314B0699, US314B0700, US314B0701, US314B0718, US314B0719, US314B0720, US314B0721, US314B0722, US314B0723, US314B0724, US314B0725, US314B0726, US314B0727, US314B0734, US314B0735, US314B0736, US314B0737, US314B0738, US314B0739, US314B0740, US314B0767, US314B0772, US314B0805, US314B0806, US314B0808, US314B0836, US314B0838, US314B0840, US314B0841, US314B0842, US414B0002, US414B0004, US414B0005, US414B0006, US414B0007, US414B0008.US414B0009, US414B0010, US414B0011, US414B0039, US414B0042, US414B0043, US414B0062, US414B0064, US414B0073, US414B0103, US414B0104, US414B0105, US414B0108, US414B0146, US414B0147, US414B0148, US414B0149, US414B0150, US414B0151, US414B0152, US414B0153, US414B0154, US414B0197, US414B0198, US414B0199, US414B0200, US414B0201, US414B0202, US414B0204, US414B0205, US414B0206, US414B0208, US414B0210, US414B0229, US414B0253, US414B0254, US414B0258, US414B0259, US414B0260, US414B0261, US414B0262, US414B0263, US414B0264, US414B0265, US414B0266, US414B0295, US414B0302, US414B0304, US414B0305, US414B0306, US414B0335, US414B0336, US414B0337, US414B0418, US414B0496, US414B0521, US414B0522, US414B0524, US414B0525, US414B0552, US414B0554, US414B0555, US414B0556, US414B0610, US414B0611, US414B0612, US513B0194, US513B0225, US513B0320, US513B0323, US513B0324, US513B0388, US513B0392, US514B0004, US514B0040, US514B0041, US514B0072, US514B0079, US514B0080, US514B0110, US514B0113, US514B0114, US514B0144, US514B0147, US514B0148, US514B0216, US613B0033, US613B0101, US613B0102, US613B0366, US713B0122, US713B0125, US713B0163, US713B0165, US713B0195, US713B0361, US713B0362, US713B0363, US713B0439, US713B0590, US713B0594, US813B0015, US813B0039, US813B0160, US813B0164, US813B0191, US813B0195, US813B0196, US813B0228, US813B0229, US813B0406, US813B0407, US813B0408, US813B0409, US813B0410, US813B0411, US913B0012, US913B0014, US913B0041, US913B0051, US913B0099, US913B0104, US913B0136, US913B0140, US913B0141, US913B0142, US913B0143, US913B0177, US913B0181, US913B0182, US913B0183, US913B0185, US913B0202, US913B0219, US913B0252, US913B0253, US913B0254, US913B0255, US913B0302, US913B0303, US913B0332, US913B0333, US913B0336, US913B0339, US913B0340, US913B0351, US913B0352, US913B0380, US913B0395, US913B0396, US913B0397, US913B0398, US913B0399, US913B0400, US913B0401, US913B0409, US913B0441, US913B0444, US913B0445, US913B0446, US913B0447, US913B0503, US913B0504, US913B0505, US913B0506, US913B0522, US913B0566, US913B0567, US913B0614, US913B0615, US913B0616, USD13B0017, USD13B0056, USD13B0057, USD13B0058, USD13B0059, USD13B0060, USD13B0063, USD13B0076, USD13B0077, USD13B0078, USD13B0079, USD13B0080, USD13B0081, USD13B0082, USD13B0083, USD13B0084, USD13B0085, USD13B0119, USD13B0147, USD13B0148, USD13B0154, USD13B0243, USD13B0244, USD13B0247, USD13B0248, USD13B0249, USD13B0250, USD13B0251, USD13B0300, USD13B0301, USD13B0302, USD13B0303, USD13B0304, USD13B0305, USD13B0306, USD13B0307, USD13B0308, USD13B0309, USD13B0310, USD13B0349, USD13B0353, USD13B0354, USD13B0355, USD13B0356, USD13B0378, USD13B0379, USD13B0381, USD13B0382, USD13B0415, USD13B0416, USD13B0423, USD13B0435, USD13B0436, USD13B0437, USD13B0438, USD13B0466, USD13B0467, USD13B0468, USD13B0489, USD13B0498, USD13B0514, USD13B0533, USD13B0534, USD13B0535, USD13B0547, USD13B0548, USD13B0549, USD13B0551, USD13B0561, USD13B0565, USD13B0566, USD13B0567, USD13B0576, USD13B0577, USD13B0578, USD13B0579, USD13B0580, USD13B0581, USD13B0582, USD13B0634, USD13B0635, USD13B0636, USD13B0640, USD13B0641, USD13B0645, USD13B0646, USD13B0647, USD13B0648, USD13B0649, USD13B0659, USD13B0664, USD13B0665, USD13B0666, USD13B0673, USD13B0674, USD13B0675, USD13B0676, USD13B0701, USD13B0702, USD13B0704, USD13B0706, USD13B0721, USD13B0775, USD13B0777, USD13B0778, USD13B0780, USD13B0785, USN13B0033, USN13B0036, USN13B0153, USN13B0154, USN13B0155, USN13B0159, USN13B0202, USN13B0203, USN13B0233, USN13B0234, USN13B0308, USN13B0333, USN13B0334, USN13B0348, USN13B0419, USN13B0420, USN13B0433, USN13B0434, USN13B0435, USN13B0436, USN13B0438, USN13B0439, USN13B0440, USN13B0464, USN13B0465, USN13B0506, USN13B0507, USN13B0510, USN13B0511, USN13B0512, USN13B0513, USN13B0514, USN13B0515, USN13B0558, USN13B0562, USN13B0563, USN13B0565, USN13B0587, USN13B0589, USN13B0590, USN13B0591, USN13B0592, USN13B0643, USN13B0650, USO13B0043, USO13B0206, USO13B0211, USO13B0213, USO13B0214, USO13B0242, USO13B0243, USO13B0244, USO13B0264, USO13B0265, USO13B0267, USO13B0287, USO13B0293, USO13B0297, USO13B0304, USO13B0311, USO13B0322, USO13B0323, USO13B0325, USO13B0326, USO13B0328, USO13B0329, USO13B0330, USO13B0331, USO13B0332, USO13B0393, USO13B0394, USO13B0441, USO13B0442, USO13B0450, USO13B0451, USO13B0452, USO13B0509, USO13B0510, USO13B0511, USO13B0512, USO13B0549, USO13B0554, USO13B0560, USO13B0561, USO13B0562, USO13B0563, USO13B0608, USO13B0609, USO13B0632, USO13B0633, USO13B0635, USO13B0643, USO13B0673, and USO13B0677.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. || Diagnostic Ultrasound Imaging.
  • Model / Serial
    SERIAL NUMBERS FOR FCO 79500317-EPIQ5 system:  US114B0005, US114B0006, US114C0193, US114C0209, US114C0239, US114C0240, US114C0241, US114C0271, US114C0272, US114C0273, US114C0284, US114C0286, US114C0287, US114C0308, US114C0331, US114C0334, US114C0366, US114C0751, US214C0043, US214C0106, US214C0140, US214C0143, US214C0144, US214C0416, US214C0417, US314C0199, US314C0298, US314C0447, US314C0728, US314C0745, US314C0800, US314C0801, US414C0012, US414C0066, US414C0114, US414C0157, US414C0158, US414C0159, US414C0395, US514C0081, USD13B0662, USD13C0033, USD13C0234, USD13C0290, USD13C0291, USD13C0481, USD13C0525, USD13C0526, USD13C0527, USD13C0572, USD13C0573, USD13C0584, USD13C0709, USN13B0039, USN13C0018, USN13C0182, USN13C0183, USN13C0184, USN13C0186, USN13C0206, USN13C0281, USN13C0282, USN13C0283, USN13C0284, USN13C0285, USN13C0286, USN13C0312, USN13C0361, USN13C0502, USN13C0503, USN13C0580, USN13C0654, USO13C0352, USO13C0354, USO13C0355, USO13C0356, USO13C0368, USO13C0369, USO13C0395, USO13C0396, USO13C0397, USO13C0398, USO13C0405, USO13C0453, USO13C0454, USO13C0596, USO13C0678, and USO13C0685.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 || Diagnostic Ultrasound Imaging.
  • Model / Serial
    ****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 Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • 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.
  • Model / Serial
    ****SYSTEM BASED ID IN THE US***********************  12DD-14B7BC8B-295F, 25EB-143A3021-2864, 3E1D-145FC2CB-28AF,  5914-14544E46-2898, 5936-13FD3F20-27EA, 91B6-1437E5A0-285F,  9C64-1478F656-28E1, A1DD-14426F8B-2874, AC8B-14838041-28F6,  C501-13FAF49F-27E5, CCFB-144184F1-2872, and J57B-147C2B71-28E8.   *****SYSTEM BASED ID OUTSIDE THE US************************  189A-13D31774-2796, 1B4E-13CD97D8-278B, 2B31-1486400F-28FC,  2B42-145AB87C-28A5, 2E29-13D2A227-2795, 3099-147B40D7-28E6,  3B7A-1439BAD4-2863, 4BD4-13C1AE06-2773, 4E88-13BC2E6A-2768,  50E7-149054AD-2910, 512B-13E23661-27B4, 539B-148AD511-2905,  564F-14855575-28FA, 5682-1402BEBC-27F5, 5E5A-14A05E34-2930,  5E6B-1474D6A1-28D9, 611F-146F5705-28CE, 66CB-13B63981-275C,  6BCD-14B067BB-2950, 6ED6-13D14240-2792, 73E9-149FE8E7-292F,  76F2-13C0C36C-2771, 7951-1494E9AF-2919, 7C05-148F6A13-290E,  7C16-1463E280-28B7, 7C49-13E14BC7-27B2, 7C5A-13B5C434-275B,  7EA8-14B5720A-295A, 8465-13D0CCF3-2791, 8C5F-14175D45-281E,  8F35-13BACE83-2765, 91E9-13B54EE7-275A, A46F-1493FF15-2917,  B74A-1499H964-2921, C4CE-147D8B58-28EA, D798-14AE1D3A-294B,  D7A9-148295A7-28F4, DA5D-147D160B-28E9, DFB4-149D9E66-292A,  DFC5-147216D3-28D3, E268-14981ECA-291F, E7BF-14B8A725-2960,  EA95-145C1863-28A7, ED7C-13D4H20E-2797, F598-13C3833A-2776,  FDA3-13DE8BF9-27AC, and XAF4-1445A4A6-287B.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA and WI. Also distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland.
  • Product Description
    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
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2 manufacturers with a similar name

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  • Manufacturer Address
    Philips Ultrasound, Inc., 22100 Bothell-Everett Hwy., P.O. Box 3003, Bothell WA 98041-3003
  • Source
    USFDA
  • Manufacturer Parent Company (2017)
  • Source
    ANVSANVISA