Ge Healthcare GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.
Brand
Ge Healthcare
Lot Codes / Batch Numbers
Serial Numbers: D00210, D00223, D00225, D00239, D00241, D00293, D00326, D00347, D00415, D00425, D00435, D00445, D00455, D00456, D00459, D00460, D00465, D00467, D00468, D00469, D00480, D00481, D00484, D00485, D00487, D00490, D00491, D00493, D00495, D00502, D00503, D00505, D00512, D00516, D00517, D00523, D00525, D00531, D00532, D00537, D00539, D00541, D00542, D00543, D00546, D00548, D00550, D00551, D00552, D00554, D00558, D00560, D00561, D00562, D00563, D00564, D00565, D00566, D00567, D00568, D00569, D00570, D00571, D00572, D00573, D00574, D00575, D00576, D00577, D00579, D00580, D00581, D00582, D00625, D00627, D00628, D00632, D00633, D00636, D00638, D00639, D00640, D00649, D00652, D00653, D00655, D00665, D00666, D00668, D00108, D00123, D00134, D00139, D00168, D00173, D00176, D00178, D00182, D00185, D00186, D00187, D00189, D00192, D00193, D00194, D00195, D00198, D00199, D00200, D00203, D00209, D00214, D00220, D00224, D00226, D00227, D00228, D00230, D00231, D00232, D00233, D00236, D00242, D00243, D00244, D00246, D00249, D00252, D00254, D00258, D00282, D00291, D00292, D00295, D00296, D00297, D00299, D00300, D00302, D00303, D00304, D00305, D00306, D00307, D00310, D00312, D00314, D00316, D00317, D00318, D00319, D00327, D00330, D00335, D00336, D00337, D00339, D00340, D00343, D00344, D00346, D00349, D00350, D00351, D00352, D00354, D00355, D00356, D00359, D00361, D00362, D00364, D00366, D00367, D00372, D00374, D00375, D00388, D00391, D00392, D00393, D00395, D00396, D00397, D00398, D00399, D00402, D00403, D00404, D00405, D00406, D00411, D00413, D00418, D00420, D00421, D00422, D00423, D00426, D00451, D00180, D00379, D00387, D00430, D00433, D00444, D00454, D00464, D00470, D00476, D00497, D00509, D00513, D00522, D00526, D00540, D00544, D00545, D00547, D00549, D00553, D00555, D00556, D00557, D00559, D00585, D00586, D00103, D00155, D00166, D00250, D00251, D00255, D00325, D00331, D00595, D00584, D00280, D00342, D00369, D00148, D00213, D00301, D00428, D00601, D00602, D00603, D00604, D00324, D00151, D00471, D00519, D00593, D00466, D00494, D00659, D00432, D00473, D00321, D00591, D00599, D00153, D00217, D00222, D00248, D00437, D00514, D00322, D00449, D00474, D00475, D00478, D00504, D00507, D00508, D00521, D00528, D00529, D00533, D00534, D00583, D00634, D00635, D00641, D00644, D00645, D00663, D00126, D00128, D00240, D00272, D00277, D00279, D00332, D00341, D00407, D00419, D00486, D00424, D00499, D00288, D00308, D00394, D00483, D00143, D00117, D00138, D00150, D00165, D00167, D00183, D00218, D00245, D00253, D00259, D00261, D00264, D00315, D00328, D00378, D00383, D00385, D00431, D00462, D00613, D00618, D00121, D00141, D00154, D00170, D00171, D00190, D00234, D00256, D00267, D00311, D00313, D00461, D00145, D00146, D00196, D00201, D00205, D00206, D00207, D00257, D00263, D00266, D00268, D00410, D00438, D00439, D00458, D00479, D00488, D00489, D00496, D00511, D00518, D00520, D00527, D00538, D00594, D00596, D00598, D00600, D00605, D00621, D00660, D00661, D00179, D00202, D00204, D00208, D00215, D00219, D00221, D00237, D00260, D00265, D00271, D00275, D00276, D00281, D00285, D00286, D00287, D00353, D00358, D00360, D00365, D00429, D00309, D00334, D00368, D00477, D00482, D00149, D00152, D00289, D00290, D00323, D00401, D00211, D00144, D00181, D00191, D00269, D00472, D00588, D00589, D00161, D00162, D00164, D00229, D00329, D00370, D00371, D00390, D00427, D00160, D00212, D00283, D00320, D00122, D00137, D00156, D00377, D00409, D00434, D00446, D00447, D00450, D00452, D00453, D00463, D00492, D00506, D00510, D00515, D00524, D00530, D00535, D00578, D00587, D00590, D00592, D00597, D00606, D00607, D00608, D00609, D00610, D00611, D00612, D00614, D00615, D00616, D00617, D00619, D00620, D00622, D00623, D00624, D00626, D00629, D00630, D00631, D00642, D00643, D00647, D00650, D00651, D00654, D00656, D00658, D00662, D00664, D00667, D00669, D00670, D00672, D00101, D00105, D00107, D00113, D00125, D00127, D00131, D00132, D00135, D00136, D00158, D00163, D00175, D00188, D00278, D00294.D00333, D00357, D00373, D00376, D00381, D00382, D00384, D00386, D00389, D00400, D00408, D00412, D00414, D00416, D00417, D00436, D00440, D00441, D00442, D00443, D00498, D00500, D00501. Version 6.2.0 was distributed 3/24/07 and version 6.2.1: 4/10/07
Products Sold
Serial Numbers: D00210, D00223, D00225, D00239, D00241, D00293, D00326, D00347, D00415, D00425, D00435, D00445, D00455, D00456, D00459, D00460, D00465, D00467, D00468, D00469, D00480, D00481, D00484, D00485, D00487, D00490, D00491, D00493, D00495, D00502, D00503, D00505, D00512, D00516, D00517, D00523, D00525, D00531, D00532, D00537, D00539, D00541, D00542, D00543, D00546, D00548, D00550, D00551, D00552, D00554, D00558, D00560, D00561, D00562, D00563, D00564, D00565, D00566, D00567, D00568, D00569, D00570, D00571, D00572, D00573, D00574, D00575, D00576, D00577, D00579, D00580, D00581, D00582, D00625, D00627, D00628, D00632, D00633, D00636, D00638, D00639, D00640, D00649, D00652, D00653, D00655, D00665, D00666, D00668, D00108, D00123, D00134, D00139, D00168, D00173, D00176, D00178, D00182, D00185, D00186, D00187, D00189, D00192, D00193, D00194, D00195, D00198, D00199, D00200, D00203, D00209, D00214, D00220, D00224, D00226, D00227, D00228, D00230, D00231, D00232, D00233, D00236, D00242, D00243, D00244, D00246, D00249, D00252, D00254, D00258, D00282, D00291, D00292, D00295, D00296, D00297, D00299, D00300, D00302, D00303, D00304, D00305, D00306, D00307, D00310, D00312, D00314, D00316, D00317, D00318, D00319, D00327, D00330, D00335, D00336, D00337, D00339, D00340, D00343, D00344, D00346, D00349, D00350, D00351, D00352, D00354, D00355, D00356, D00359, D00361, D00362, D00364, D00366, D00367, D00372, D00374, D00375, D00388, D00391, D00392, D00393, D00395, D00396, D00397, D00398, D00399, D00402, D00403, D00404, D00405, D00406, D00411, D00413, D00418, D00420, D00421, D00422, D00423, D00426, D00451, D00180, D00379, D00387, D00430, D00433, D00444, D00454, D00464, D00470, D00476, D00497, D00509, D00513, D00522, D00526, D00540, D00544, D00545, D00547, D00549, D00553, D00555, D00556, D00557, D00559, D00585, D00586, D00103, D00155, D00166, D00250, D00251, D00255, D00325, D00331, D00595, D00584, D00280, D00342, D00369, D00148, D00213, D00301, D00428, D00601, D00602, D00603, D00604, D00324, D00151, D00471, D00519, D00593, D00466, D00494, D00659, D00432, D00473, D00321, D00591, D00599, D00153, D00217, D00222, D00248, D00437, D00514, D00322, D00449, D00474, D00475, D00478, D00504, D00507, D00508, D00521, D00528, D00529, D00533, D00534, D00583, D00634, D00635, D00641, D00644, D00645, D00663, D00126, D00128, D00240, D00272, D00277, D00279, D00332, D00341, D00407, D00419, D00486, D00424, D00499, D00288, D00308, D00394, D00483, D00143, D00117, D00138, D00150, D00165, D00167, D00183, D00218, D00245, D00253, D00259, D00261, D00264, D00315, D00328, D00378, D00383, D00385, D00431, D00462, D00613, D00618, D00121, D00141, D00154, D00170, D00171, D00190, D00234, D00256, D00267, D00311, D00313, D00461, D00145, D00146, D00196, D00201, D00205, D00206, D00207, D00257, D00263, D00266, D00268, D00410, D00438, D00439, D00458, D00479, D00488, D00489, D00496, D00511, D00518, D00520, D00527, D00538, D00594, D00596, D00598, D00600, D00605, D00621, D00660, D00661, D00179, D00202, D00204, D00208, D00215, D00219, D00221, D00237, D00260, D00265, D00271, D00275, D00276, D00281, D00285, D00286, D00287, D00353, D00358, D00360, D00365, D00429, D00309, D00334, D00368, D00477, D00482, D00149, D00152, D00289, D00290, D00323, D00401, D00211, D00144, D00181, D00191, D00269, D00472, D00588, D00589, D00161, D00162, D00164, D00229, D00329, D00370, D00371, D00390, D00427, D00160, D00212, D00283, D00320, D00122, D00137, D00156, D00377, D00409, D00434, D00446, D00447, D00450, D00452, D00453, D00463, D00492, D00506, D00510, D00515, D00524, D00530, D00535, D00578, D00587, D00590, D00592, D00597, D00606, D00607, D00608, D00609, D00610, D00611, D00612, D00614, D00615, D00616, D00617, D00619, D00620, D00622, D00623, D00624, D00626, D00629, D00630, D00631, D00642, D00643, D00647, D00650, D00651, D00654, D00656, D00658, D00662, D00664, D00667, D00669, D00670, D00672, D00101, D00105, D00107, D00113, D00125, D00127, D00131, D00132, D00135, D00136, D00158, D00163, D00175, D00188, D00278, D00294.D00333, D00357, D00373, D00376, D00381, D00382, D00384, D00386, D00389, D00400, D00408, D00412, D00414, D00416, D00417, D00436, D00440, D00441, D00442, D00443, D00498, D00500, D00501. Version 6.2.0 was distributed 3/24/07 and version 6.2.1: 4/10/07
Ge Healthcare is recalling GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations due to When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.
Recommended Action
Per FDA guidance
GE Healthcare sent customer letters on July 15, 2007 to affected customers. The letter included a short term mitigation recommendation and a long-term correction. The long-term correction will be software upgrade provided free of charge to all affected customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026