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Terminated

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

FDA Recall Z-1171-2010 · Posted 2010-03-19

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2007-11-12
Date Terminated2012-04-18
Product Quantity8 units

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041499SSA-770A, APLIO VERSION 5.5Toshibamedical Systems Corporation · 2004-06-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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