Z-0985-2007

Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software

Name: Z-0985-2007 Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software
Creator: Toshiba American Med Sys Inc
Published: 2007-02-02
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2007-02-02 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software on 2007-02-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0985-2007
Status: Terminated
Initiated: 2007-02-02
Posted: 2007-06-27
Terminated: 2012-04-18
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 260
Distribution: Nationwide
Product codes and lots: 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

Product code IYN

K041499Class IISsa-770A, Aplio Version 5.5Toshibamedical Systems Corporation / cleared 2004-06-10

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)