Xario; SSA-660A; software version 1.0 and later
FDA device recall Z-1173-2010 · posted 2010-03-19 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 98 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2007-11-12
- Date posted
- 2010-03-19
- Date terminated
- 2012-04-18
- Location
- Tustin, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A (K050380) | Toshiba America Medical Systems, In.C | 2005-02-23 |