Z-0113-2008

GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with...

Name: Z-0113-2008 GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with...
Creator: Ge Healthcare
Published: 2007-07-06
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-07-06 / Terminated / root cause: software

FDA source

Ge Healthcare began a recall of 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... on 2007-07-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0113-2008
Status: Terminated
Initiated: 2007-07-06
Posted: 2007-11-07
Terminated: 2008-10-21
Recalling firm: GE Healthcare
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.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 521 Units
Distribution: Nationwide.
Product codes and lots: 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

Product code IYO

K061682Class IIGe Voluson E8 Ultrasound SystemGeneral Electric Co. / cleared 2006-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)