Z-1171-2010

Aplio 50; SSA-700A; software version 5.5r002

Name: Z-1171-2010 Aplio 50; SSA-700A; software version 5.5r002
Creator: Toshiba American Medical Systems Inc
Published: 2007-11-12
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2007-11-12 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of Aplio 50; SSA-700A; software version 5.5r002 on 2007-11-12. The reason FDA records is "Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1171-2010
Status: Terminated
Initiated: 2007-11-12
Posted: 2010-03-19
Terminated: 2012-04-18
Recalling firm: Canon Medical Systems USA, Inc.
Product: Aplio 50; SSA-700A; software version 5.5r002
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.
Root cause tag: design
FDA root cause: Component design/selection
Action: Toshiba America Medical Systems (TAMS) has issued a Field Modification Instruction notification to all of its customers about the affected devices. The correct software will be administered through TAMS' representatives. Reimbursement for the modification will be given upon receipt of the reimbursement claim invoice.
Quantity in commerce: 8 units
Distribution: Nationwide Distribution
Product codes and lots: F4603656, F4603654, F4613731, F5513813, F4613730, F4613732, G5523875, G5523871, A2542234, F4603309, F450331, F4603314, F4603317, D3622941, F4603315, F4623389, F4613351, F4613356, F4613352, F4613353, F5513467, F4613339, F5513458, F5513433, F5513448, F5513452, F5513431, F5513439, F4613344, F5513455, F4623391, F5513464, F4623378, F4313338, F4613341, F4613343, F5513437, F5513451, F5513469, 5F513450, F4623379, F4623388, F4623375, F4623383, F5513446, F4623392, F5513449, F4613337, F4623381, F4623377, F5513460, F4623380, F4613342, F5513430, F5513463, F5513445, F4623390, F5513461, F5513462, F5513432, 80G0543639, 80G0543628, 80G0593786, G5523558, 80G0543644, 80G0543643, G5523519, G5523536, G5523544, 80G0523567, 80G0593789, 80G0593774, G5523513, G5523514, G5523564, G5523563, 80G0543637, G5523562, 80G0583731, 80G0593794, 80G0583728, 80G0593790, 80G0593791, 80G0593773, 80G0543640, 80G0593793, 80G0523565, 80G0543636, 80G0543645, G5523538, 80G0543627, 80G0583730, 80G0593792, G5523559, 80G0543625, G5523539, G5523541, G5523537, 80G0583727, 80G0593785, 80G0593802, and 80G0593803.

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)