Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound syst
FDA device recall Z-2897-2011 · posted 2011-07-29 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- 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.).
- Action taken
- 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 or contact your local Toshiba Representative at (800) 521-1968.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 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.
- Date initiated
- 2010-10-01
- Date posted
- 2011-07-29
- Date terminated
- 2012-04-20
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APLIO ARTIDA V2.0 SSH-880CV (K090158) | Toshiba America Medical Systems, In.C | 2009-02-06 |