NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0,Toshiba America
FDA device recall Z-0254-2008 · posted 2007-11-17 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.
- Action taken
- Urgent Medical Device Notification letters were sent to customers on August 29, 2007. Customers were notified of the several issues related to the Nemio SSA-550A and Nemio SSA-580A recall and asked to share this information with all users of the device. Customers were informed that Toshiba is preparing software and corrected manuals for distribution to address these issues. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 128 units
- Distribution
- Nationwide
- Date initiated
- 2007-08-29
- Date posted
- 2007-11-17
- Date terminated
- 2012-04-05
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEMIO XG, SAA-580A (K061605) | Toshiba America Medical Systems, In.C | 2006-06-22 |