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.

Reason: 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.

Code information: 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.

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.