SSH-880CV Aplio Artida; System, Diagnostic Ultrasound
FDA device recall Z-1498-2011 · posted 2011-03-03 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 40 units
- Distribution
- Nationwide Distribution to CA, GA, IA, IL KY, LA, MA, MN, MT, OH, OR, PA, TX, WI, and Puerto Rico.
- Date initiated
- 2010-09-28
- Date posted
- 2011-03-03
- Date terminated
- 2012-05-02
- 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 |