Toshiba American Medical Systems Inc Xario; SSA-660A; software version 1.0 and later Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Xario; SSA-660A; software version 1.0 and later
Brand
Toshiba American Medical Systems Inc
Lot Codes / Batch Numbers
99B0552623, 99B0552625, 99B0552649, 99B0552629, 99B0562684, 99B0552648, 99B0593233, 99B0552592, 99B0583053, 99B0572841, 99B0562671, 99B0562673, 99B0572834, 99B0572894, 99B0552590, 99B0572895, 99B0562672, 99B0572839, 599B052651, 99B0593228, 99B0562685, 99B0593227, 99B0552612, 99B0572840, 99B0552650, 99B0562674, 99B0552652, 99B0552653, 99B0552654, 99B0552646, 99B0552627, 99B0552574, 99B0572898, 99B0472046, 99B0583050, 99B0562689, 99B0572821, 99B0572897, 99B0572835, 99B0572837, 99B0572838, 99B0572836, 99B0572822, 99B0552615, 99B0552616, 99B0552621, 99B0552597, 99B0593210, 99B0552598, 99B0552647, 99B0552655, 99B0552593, 99B0552591, 99B0593236, 99B0552577, 99B0552579, 99B0552630, 99B0583049, 99B0552569, 99B0552567, 99B0593213, 99B0552617, 99B0552624, 99B0552599, 99B0583048, 99B0583052, 99B0593211, 99B0552595, 99B0552619, 99B0552620, 99B0593229, 99B0593230, 99B0583047, 99B0583045, 99B0552594, 99B0552578, 99B0552568, 99B0552575, 99B0552576, 99B0552631, 99B0552570, 99B0552613, 99B0552626, 99B0562686, 99B0583051, 99B0593235, 99B0552618, 99B0562687, 99B0593234, 99B0593232, 99B0552614, 99B0552628, 99B0572869, 99B0552584, 99B0593231, 99B0552622, 99B0562675, 99B0593209, and 99B0593212.
Products Sold
99B0552623, 99B0552625, 99B0552649, 99B0552629, 99B0562684, 99B0552648, 99B0593233, 99B0552592, 99B0583053, 99B0572841, 99B0562671, 99B0562673, 99B0572834, 99B0572894, 99B0552590, 99B0572895, 99B0562672, 99B0572839, 599B052651, 99B0593228, 99B0562685, 99B0593227, 99B0552612, 99B0572840, 99B0552650, 99B0562674, 99B0552652, 99B0552653, 99B0552654, 99B0552646, 99B0552627, 99B0552574, 99B0572898, 99B0472046, 99B0583050, 99B0562689, 99B0572821, 99B0572897, 99B0572835, 99B0572837, 99B0572838, 99B0572836, 99B0572822, 99B0552615, 99B0552616, 99B0552621, 99B0552597, 99B0593210, 99B0552598, 99B0552647, 99B0552655, 99B0552593, 99B0552591, 99B0593236, 99B0552577, 99B0552579, 99B0552630, 99B0583049, 99B0552569, 99B0552567, 99B0593213, 99B0552617, 99B0552624, 99B0552599, 99B0583048, 99B0583052, 99B0593211, 99B0552595, 99B0552619, 99B0552620, 99B0593229, 99B0593230, 99B0583047, 99B0583045, 99B0552594, 99B0552578, 99B0552568, 99B0552575, 99B0552576, 99B0552631, 99B0552570, 99B0552613, 99B0552626, 99B0562686, 99B0583051, 99B0593235, 99B0552618, 99B0562687, 99B0593234, 99B0593232, 99B0552614, 99B0552628, 99B0572869, 99B0552584, 99B0593231, 99B0552622, 99B0562675, 99B0593209, and 99B0593212.
Toshiba American Medical Systems Inc is recalling Xario; SSA-660A; software version 1.0 and later due to 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; . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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