Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software
- Company
- Toshiba American Med Sys Inc
- Recall Initiated
- February 2, 2007
- Posted
- June 27, 2007
- Terminated
- April 18, 2012
- Recall Number
- Z-0985-2007
- Quantity
- 260
- Firm Location
- Tustin, CA
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
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
Root Cause
Other
Action Taken
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.