Recall Z-2897-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Medical Systems Inc
Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system.
| Date | Jul 29, 2011 (initiated Oct 1, 2010) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, ect.). |
| Root cause | Software design |
| Action | Toshiba America Medical Systems, Inc. sent out an "Urgent Medical Device Correction" dated December 21, 2010 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Toshiba will issue a field modification to correct the software, and if the problem occurs, they were instructed to shutdown the system holding down the power supply button for 5 seconds for 5 seconds and then restart the system. A form to send back to Toshiba is included. For questions on this recall call (800) 421-1968 |
| Quantity | 46 units |
| Distribution | Worldwide Distribution: (USA) Nationwide distribution including the states of MD, OH, PA, NY, MA, GA, AL, TX, IL, WI, IA, MN, KY, MT, OR, LA, and CA; and the country of Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090158 | APLIO ARTIDA V2.0 SSH-880CV Toshiba America Medical Systems, In.C, Feb 6, 2009 |