FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: SSH-880CV Aplio Artida; System, Diagnostic Ultrasound
- Recall number
- Z-1498-2011
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- SSH-880CV Aplio Artida; System, Diagnostic Ultrasound
- Status
- Terminated
- Initiated
- 2010-09-28
- Posted
- 2011-03-03
- Terminated
- 2012-05-02
- 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.
- Lot, serial or model codes
- Serial Numbers (last 4): 2031, 2033, 2069, 2070, 2072, 2073, 2074, 2076, 2077, 2079, 2087, 2088, 2103, 2105, 2107, 2120, 2205, 2206, 2218, 2219, 2220, 2260, 2262, 2268, 2270, 2271, 2272, 2273, 2280, 2281, 2311, 2313, 2334, 2335, 2340, 2341, 2347, 2348, 2360, 2361, 2389, 2390, 2405, 2032, 2048, 2049, 2056, 2071, 2075, 2078, 2080, 2104, 2106, 2108, 2119, 2123, 2124, 2204, 2261, 2282, 2296, 2297, 2312, 2342, 2389, 2390, 2405
- 510(k) numbers
- ["K090158"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28