Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating
Toshiba is recalling 427 Aplio MX Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential burn injury from overheating) where specific injury counts are not reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 427 units of the Aplio MX Diagnostic Ultrasound System SSA-780A. These devices are used for routine diagnostic imaging and were distributed nationwide, including in Puerto Rico.
The recall was initiated because the temperature of the transducer head may increase under certain conditions. Specifically, this overheating can occur when the system is used in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. The source text notes that the temperature may increase and possibly cause harm, though specific injury reports are not detailed in the provided excerpt.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall documentation. Users should stop using the affected systems in the specified modes and contact Toshiba American Medical Systems Inc for further instructions on remediation or replacement.
The recalled product
- Product
- Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
Distribution
Part of a larger recall action
This product is one of 4 recalled by Toshiba American Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →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 · burn injury
See all →- SeverePrepared Hero Recalls Fire Spray Canisters Due to Rupture Risk
CPSC · 2026-09-10
- SevereSweet Cubby Recalls Children's Loungewear Sets Due to Burn Hazard
CPSC · 2026-09-10
- Severe
- High
- SevereAmana Through-The-Wall Air Conditioners Recalled Due to Fire Risk
CPSC · 2026-09-03