Company:Toshiba American Med Sys Inc
Date of Enforcement Report:7/4/2007
Class:ll
PRODUCT
a) Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software,
Recall # Z-0985-2007;
b) Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software,
Recall # Z-0986-2007
REASON
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.
CODE
a) 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, A254224,
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;
b) Serial numbers: B2622263, B2622264, B2622265, B2622267, B2622269, B3522364, B3522365,
B3522366, B3522369, B3522370, B3522372, B3522373, B3522402, B3522403, B3522404, B3522405,
B3552542, B3552557, B3552558, B3552560, B3562595, B3562599, B3582672, B3582673, B3582674,
C3592771, C3592772, C3592773, C3592774, D4553251, D4553252, D4553253, D4563327, D4563329,
E4593563, E4593564, F4603654, F4603655, F4603656, F4613730, F4613731, F4613732, F5513813,
G5523871 & G5523875
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters on February 2, 2007.
Manufacturer: Toshiba Medical Systems Corp., Tokyo, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
305 units
DISTRIBUTION
Nationwide
