FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: APLIO 300 TUS-A300 diagnostic ultrasound system
- Recall number
- Z-2710-2017
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- APLIO 300 TUS-A300 diagnostic ultrasound system
- Status
- Terminated
- Initiated
- 2017-05-01
- Posted
- not on file
- Terminated
- 2023-10-11
- Reason
- When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Toshiba Medical sent an Urgent Medical Device Correction letter on May 1, 2017. The consignee is instructed not to use the Continuous Trace method for cardiac velocity trace measurements to quantify the MPG values. Modified software is being provided. A Toshiba service representative will contact the consignee to make an appointment to install the modified software to fix the problem. Customers were asked to complete the form and fax it to the toll-free number shown at the top of the form. The form can also be sent by email to RAffairs@tams.com. Customers with questions were instructed to call 800-521-1968.
- Quantity
- 90 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Serial Numbers: AAC1692086, AAC1692087, AAC1692088, AAC1692089, AAC1692090, AAC16Y2091, AAC16Y2092, AAC16Y2093, AAC16Y2094, AAC16Y2095, AAC16Y2096, AAC16Y2097, AAC16Y2098, AAC16Y2099, AAC16Y2100, AAD16Z2101, AAD16Z2102, AAD16Z2103, AAD16Z2104, AAD16Z2105, AAD1712106, AAD1712107, AAD1712108, AAD1712109, AAD1712110, AAD1712111, AAD1712112, AAD1722114, AAD1722115, AAD1722116, AAD1722117, AAA1652011, AAA1652012, AAA1652013, AAA1652014, AAA1652015, AAA1672026, AAA1672027, AAA1672028, AAA1672029, AAA1672030, AAA1672031, AAA1672032, AAA1672033, AAA1672034, AAA1672035, AAA1672036, AAA1672037, AAA1672038, AAA1672040, AAA1682041, AAA1682042, AAA1682043, AAA1682044, AAA1682045, AAA1682046, AAA1682047, AAA1682048, AAA1682049, AAA1682051, AAA1682052, AAA1682053, AAA1682054, AAA1692056, AAA1692057, AAA1692058, AAA1692059, AAA1692060, AAA1712011, AAA1712012, AAA1712013, AAA1712014, AAA1712015, AAA1712016, AAA1712017, AAA1722022, AAA1722023, AAA1722024, AAA1722036, AAA1722038, AAA1722039, AAA1722040, AAA1722041, AAA1722042, AAA1722043, AAA1722044, AAA1722045, AAA1732046, AAA1732047, AAA1732049.
- 510(k) numbers
- ["K151451"]
- 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