Toshiba American Med Sys Inc Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software
Brand
Toshiba American Med Sys Inc
Lot Codes / Batch Numbers
Serial numbers: 80G0543625, 80G0543628, 80G0543636, 80G0543637, 80G0543639, 80G0543640, 80G0543643, 80G0543644, 80G0543645, 80G0583727, 80G0583728, 80G0583730, 80G0583731, 80G0593773, 80G0593785, 80G0593786, 80G0593789, 80G0593790, 80G0593791, 80G0593792, 80G0593793, 80G0593794, 80G05X3837, 80G05X3839, 80G05X3852, 80G05X3853, 80G05X3854, 80G05X3855, 80G05Y3866, 80G05Y3867, 80G05Y3870, 80G05Y3871, 80G05Y3872, 80G05Y3873, 80G05Y3874, 80G05Y3883, 80G05Y3884, 80G05Y3887, 80G05Y3889, 80G05Y3890, A1627001, A1627002, A1627003, A2532207, A2532209, A2532210, A2532211, A2542221, A2542223, A2542224, A2542225, A2542228, A2542229, A2542230, A2542232, A2542234, A2542235, A2542236, A2552260, A2552261, A2552262, A2552297, A2552298, A2552299, A2562305, A2562307, A2562309, A2592415, A2592420, A2602427, A2602430, A2602432, A2602435, A2602436, A2602437, A2602438, A4583197, B3522582, B3532463, B3532464, B3532533, B3532534, B3532602, B3532603, B3542624, B3542625, B3542626, B3542627, B3542628, B3542629, B3552647, B3552648, B3552649, B3552651, B3552667, B3552669, B3552672, B3552673, B3562677, B3562678, B3562679, B3562680, B3562681, B3562694, B3562697, B3562700, B3572727, B3572732, C3592781, C3592783, C3592784, C3602834, C3602836, C3612855, C3612856, C3612857, C3612870, C36l 2872, C3612874, C3612875, C361 2877, C3612882, C3612883, C3612885, C3612886, C3612887, C3612888, C3612889, C3612891, C3612892, C3612893, C3612894, C3622938, C3622939, D3622940, D3622945, D3622947, D4532657, D4532658, D4532660, D4532663, D4533034, D4533038, D4533039, D4533041, D4533042, D4533043, D4533044, D4533048, D4533051, D4533052, D4533054, D4533055, D4533056, D4543084, D4543085, D4543086, D4543088, D4543091, D4543092, D4543093, D4553108, D4553109, D4553111, D4553112, D4553121, D4553123, D4553124 D4553125, D4553126, D4563136, D4563141, D4563142, D4563143, D4573166, D4573167, D4573168, D4573169, D4573170, E4583194, E4583195, E4583196, E4583198, E4583201, E4583202, E4583206, E4583207, E4583208, E4583211, E4593250, E4593254, E4593255, E4593262, E4593263, E4593264, E4593267, E4593268, E4593270, E4593273, E4593274, E4593276, E4593278, E4593281, F4603311, F4603314, F4603317, F4613337, F4613338, F4613339, F4613341, F4613342, F4613343, F4613344, F4613351, F4613352, F4613353, F4613356, F4623375, F4623377, F4623378, F4623380, F4623381, F4623382, F4623383, F4623388, F4623389, F4623391, F4623392, F5513431, F5513433, F5513437, F5513439, F5513445, F5513446, F5513448, F5513449, F5513450, F5513452, F5513455, F5513460, F5513461, F5513462, F5513463, F5513464, F5513467, F5513459, G5522743, G5523512, G5523513, G5523514, G5523519, G5523541, G5523544, G5523558, G5523559, G5523562, G5523563, G5523564, G5523565 & G5523567
Products Sold
Serial numbers: 80G0543625, 80G0543628, 80G0543636, 80G0543637, 80G0543639, 80G0543640, 80G0543643, 80G0543644, 80G0543645, 80G0583727, 80G0583728, 80G0583730, 80G0583731, 80G0593773, 80G0593785, 80G0593786, 80G0593789, 80G0593790, 80G0593791, 80G0593792, 80G0593793, 80G0593794, 80G05X3837, 80G05X3839, 80G05X3852, 80G05X3853, 80G05X3854, 80G05X3855, 80G05Y3866, 80G05Y3867, 80G05Y3870, 80G05Y3871, 80G05Y3872, 80G05Y3873, 80G05Y3874, 80G05Y3883, 80G05Y3884, 80G05Y3887, 80G05Y3889, 80G05Y3890, A1627001, A1627002, A1627003, A2532207, A2532209, A2532210, A2532211, A2542221, A2542223, A2542224, A2542225, A2542228, A2542229, A2542230, A2542232, A2542234, A2542235, A2542236, A2552260, A2552261, A2552262, A2552297, A2552298, A2552299, A2562305, A2562307, A2562309, A2592415, A2592420, A2602427, A2602430, A2602432, A2602435, A2602436, A2602437, A2602438, A4583197, B3522582, B3532463, B3532464, B3532533, B3532534, B3532602, B3532603, B3542624, B3542625, B3542626, B3542627, B3542628, B3542629, B3552647, B3552648, B3552649, B3552651, B3552667, B3552669, B3552672, B3552673, B3562677, B3562678, B3562679, B3562680, B3562681, B3562694, B3562697, B3562700, B3572727, B3572732, C3592781, C3592783, C3592784, C3602834, C3602836, C3612855, C3612856, C3612857, C3612870, C36l 2872, C3612874, C3612875, C361 2877, C3612882, C3612883, C3612885, C3612886, C3612887, C3612888, C3612889, C3612891, C3612892, C3612893, C3612894, C3622938, C3622939, D3622940, D3622945, D3622947, D4532657, D4532658, D4532660, D4532663, D4533034, D4533038, D4533039, D4533041, D4533042, D4533043, D4533044, D4533048, D4533051, D4533052, D4533054, D4533055, D4533056, D4543084, D4543085, D4543086, D4543088, D4543091, D4543092, D4543093, D4553108, D4553109, D4553111, D4553112, D4553121, D4553123, D4553124 D4553125, D4553126, D4563136, D4563141, D4563142, D4563143, D4573166, D4573167, D4573168, D4573169, D4573170, E4583194, E4583195, E4583196, E4583198, E4583201, E4583202, E4583206, E4583207, E4583208, E4583211, E4593250, E4593254, E4593255, E4593262, E4593263, E4593264, E4593267, E4593268, E4593270, E4593273, E4593274, E4593276, E4593278, E4593281, F4603311, F4603314, F4603317, F4613337, F4613338, F4613339, F4613341, F4613342, F4613343, F4613344, F4613351, F4613352, F4613353, F4613356, F4623375, F4623377, F4623378, F4623380, F4623381, F4623382, F4623383, F4623388, F4623389, F4623391, F4623392, F5513431, F5513433, F5513437, F5513439, F5513445, F5513446, F5513448, F5513449, F5513450, F5513452, F5513455, F5513460, F5513461, F5513462, F5513463, F5513464, F5513467, F5513459, G5522743, G5523512, G5523513, G5523514, G5523519, G5523541, G5523544, G5523558, G5523559, G5523562, G5523563, G5523564, G5523565 & G5523567
Toshiba American Med Sys Inc is recalling Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software due to When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue has been reported with these values.
Recommended Action
Per FDA guidance
Notification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.
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