Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software
FDA device recall Z-0985-2007 · posted 2007-06-27 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue has been reported with these values.
- Action taken
- Notification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. 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. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 260
- Distribution
- Nationwide
- Date initiated
- 2007-02-02
- Date posted
- 2007-06-27
- Date terminated
- 2012-04-18
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SSA-770A, APLIO VERSION 5.5 (K041499) | Toshibamedical Systems Corporation | 2004-06-10 |