Recall Z-0305-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Med Sys Inc
Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780
| Date | Jan 9, 2008 (initiated Oct 2, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063130 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 Toshibamedical Systems Corporation, Nov 2, 2006 |