FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780
- Recall number
- Z-0305-2008
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780
- Status
- Terminated
- Initiated
- 2007-10-02
- Posted
- 2008-01-09
- Terminated
- 2012-04-20
- Reason
- Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.
- Root cause
- Software design
- Action
- Notification letters, Urgent Medical Device Correction, with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.--A short term instruction included "Avoid using the Freeze Key when performing dynamic image acquisitions"
- Quantity
- 69
- Distribution
- Nationwide: USA including the states of AK, AZ, CA, FL, IA, IL, IN, KS, MI, MN, MO, MT, NE, NV, NY, OH, OR, PR, VA, WI & WV
- Lot, serial or model codes
- SERIAL NUMBERS: 99B0752571, 99B0752572, 99B06Z2073, 99B06Z2102, 99B06Z2107, 99B0722268, 99B0722269, 99B0722270, 99B0722271, 99B0722272, 99B0732349, 99B0732350, 99B0732351, 99B0732352, 99B0732353, 99B0732354, 99B0722208, 99B0722250, 99B0752531, 99B0752532, 99B06Z2072, 99B0752508, 99B0752509, 99B0752510, 99B0752511, 99B0722251, 99B06Z2071, 99B0722206, 99B0722207, 99B0722204, 99B0752524, 99B0752525, 99B0732355, 99B0742413, 99B0742414, 99B0742415, 99B0742416, 99B0742417, 99B0722203, 99B06Z2062, 99B0722201, 99B0712171, 99B0722254, 99B0752507, 99B06Z2064, 99B06Z2104, 99B0712169, 99B0712172, 99B0722202, 99B0752570, 99B0752562, 99B0752563, 99B0752564, 99B0752565, 99B06Z2103, 99B0752523, 99B0752550, 99B06Z2074, 99B0712173, 99B0712174, 99B06Z2059, 99B0752551, 99B0752561, 99B06Z2108, 99B0752549, 99B0722205, 99B0752547, 99B0712168, 99B0722253, 99B06Y2048, 99B06Y2049, 99B06Y2051, 99B06Z2058, 99B06Z2067, 99B06Z2110, 99B06Z2116, 99B06Z2057, 99B06Z2088, 99B06Z2105, 99B06Z2111, 99B06Z2115, 99B0722252, 99B06Z2063, 99B06Z2065, 99B06Z2066, 99B06Z2090, 99B06Z2101, 99B06Z2113, 99B0712170, 99B06Z2060, 99B06Z2068, 99B06Z2070, 99B06Z2106, 99B0752548, 99B06Z2089, 99B06Z2091, 99B06Z2092, 99B06Y2050, 99B06Z2055, 99B06Z2056, 99B06Z2061, 99B06Z2069, 99B06Z2075, 99B06Z2109, 99B06Z2112, and 99B06Z2114
- 510(k) numbers
- ["K063130"]
- PMA numbers
- not on file
- Product code
- IYN
- 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