Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Recalled by Toshiba American Medical Systems Inc Due to Toshiba Medical Systems has received reports of startup...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Toshiba American Medical Systems Inc directly.
Affected Products
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Quantity: 233 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Toshiba American Medical Systems Inc
Toshiba American Medical Systems Inc has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report