SSH-880CV Aplio Artida System
FDA device recall Z-1955-2010 · posted 2010-07-06 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 22
- Distribution
- Nationwide ((CA, GA, IA, LA, MA, MD, MN, MT, PA, PR, OH, OR, TN).
- Date initiated
- 2009-09-16
- Date posted
- 2010-07-06
- Date terminated
- 2012-03-21
- 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 |