Philips Ultrasound, Inc.

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.

Radiology Devices

2

No

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.

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.

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.

Radiology Devices

2

No

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.

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.

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.

Radiology Devices

2

No

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.

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.

****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.

Radiology Devices

2

No

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.

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.

****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.

Radiology Devices

2

No

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.

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.