Recall Z-1498-2011 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Toshiba American Medical Systems Inc
SSH-880CV Aplio Artida; System, Diagnostic Ultrasound
| Date | Mar 3, 2011 (initiated Sep 28, 2010) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues. |
| Root cause | Software design |
| Action | Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter to consignees via USPS return receipt mail. The letter contained a return reply form that is to be faxed to TAMS at 877-349-3054 as proof of notification. Customers were instructed to share the information with all users and reviewing radiologists as well as clinical engineering or biomedical group at their facility. For questions regarding this recall call 800-421-1968 or 800-521-1968. |
| Quantity | 40 units |
| Distribution | Nationwide Distribution to CA, GA, IA, IL KY, LA, MA, MN, MT, OH, OR, PA, TX, WI, and 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 |