Aplio XG model SSA-790A Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-a
FDA device recall Z-2981-2011 · posted 2011-08-10 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Toshiba America Medical Systems Inc (TAMS) is initiating a field correction on the the Aplio XG model SSA-790A because it did not meet the requirement of clause 15b, IEC60601-1 which requires that the residual voltage shall not exceed 60V after 1 second from taking off the AC plug.
- Action taken
- Toshiba America Medical Systems (TAMS) sent an "URGENT:MEDICAL DEVICE CORRECTION' letter dated June 2, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to be careful not to touch the contacts or prongs on the AC plug within two seconds after unplugging the system from a wall socket. This precaution is to be adhered to until a Toshiba Service Representative replaces the power supply. Customers are to complete and return a Customer Reply Form and fax to 877-349-3054. Customers with questions regarding the notification should contact the Director of Regulatory Affairs at (800) 421-1968 or call their local Toshiba Representative at (800) 521-1968.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 78
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-06-02
- Date posted
- 2011-08-10
- Date terminated
- 2012-04-20
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 (K091295) | Toshiba America Medical Systems, In.C | 2009-05-15 |