Toshiba Diagnostic Ultrasound Systems Recalled for Startup Issues
Toshiba is recalling 233 Aplio 500/400/300 diagnostic ultrasound systems due to startup issues that may cause system damage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the hazard is potential damage to the system itself, with no mention of patient injury or illness, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 233 units of the Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). The affected devices are identified by item numbers TUS-A300/Wl and TUS-A500/Wl and were distributed nationwide.
The recall is due to reports of startup issues, specifically when bringing the system up from standby mode during remote use. Toshiba has determined that this issue may potentially cause damage to the system.
Healthcare facilities and users should contact Toshiba American Medical Systems Inc for further instructions on how to address the startup issue and prevent potential damage to the equipment.
The recalled product
- Product
- Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 233
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item numbers: TUS-A300/Wl and TUS-A500/Wl
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Toshiba American Medical Systems Inc
See all →- ModerateToshiba Diagnostic Ultrasound Systems Recalled for Power Supply Defect
FDA (Devices) · 2018-07-04
- ModerateToshiba INFX-8000H Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
FDA (Devices) · 2018-03-14
- HighToshiba Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Bolt Loosening
FDA (Devices) · 2018-03-14
- HighToshiba INFX-8000F Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
FDA (Devices) · 2018-03-14
- HighToshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
FDA (Devices) · 2018-03-14
Same hazard · equipment damage
See all →- HighOlympus Cystoscope Outer Sheath Recalled Due to Potential Device Tip Damage
FDA (Devices) · 2026-03-04
- ModerateIncisive CT systems recalled because tube heat exchanger screws may not be tightened
FDA (Devices) · 2025-12-10
- ModerateCT scanners recalled because tube heat exchanger screws may not be tightened
FDA (Devices) · 2025-12-10
- HighPower Express PE Centrifuge adhesive joint failure may cause component detachment
FDA (Devices) · 2024-09-11
- HighMedical Device Sample Holder Recalled for Adhesive Joint Failure
FDA (Devices) · 2024-09-11