Recall Z-1955-2010 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Toshiba American Medical Systems Inc
SSH-880CV Aplio Artida System
| Date | Jul 6, 2010 (initiated Sep 16, 2009) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems (TAMS) is initiating a field correction on the SSH-880CV Aplio Artida System due to a problem related to a wrong measurement value display in using with DICOM viewer. When an image is transferred from this system in DICOM transfer and a measurement is performed on a Doppler image in the DICOM viewer, measured values such as VTI (Velocity Time Integral) and PI/RI |
| Root cause | Software design |
| Action | The software will be replaced. To accomplish this, Toshiba America Medical Systems (TAMS) will notify consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. For questions or concerns, please contact your Toshiba representative or the firm at (714) 730-5000. |
| Quantity | 22 |
| Distribution | Nationwide ((CA, GA, IA, LA, MA, MD, MN, MT, PA, PR, OH, OR, TN). |
| 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 |