FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
- Recall number
- Z-1104-2013
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
- Status
- Terminated
- Initiated
- 2012-12-11
- Posted
- 2013-04-12
- Terminated
- 2014-04-10
- Reason
- Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.
- Root cause
- Device Design
- Action
- Toshiba sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated December 11, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (800) 421-1968 for questions regarding this letter.
- Quantity
- 233 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Item numbers: TUS-A300/Wl and TUS-A500/Wl
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITX
- 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