Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical System
FDA device recall Z-0305-2008 · posted 2008-01-09 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.
- Action taken
- Notification letters, Urgent Medical Device Correction, with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.--A short term instruction included "Avoid using the Freeze Key when performing dynamic image acquisitions"
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 69
- Distribution
- Nationwide: USA including the states of AK, AZ, CA, FL, IA, IL, IN, KS, MI, MN, MO, MT, NE, NV, NY, OH, OR, PR, VA, WI & WV
- Date initiated
- 2007-10-02
- Date posted
- 2008-01-09
- 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 1.0 (K063130) | Toshibamedical Systems Corporation | 2006-11-02 |