Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating
Toshiba is recalling 477 Xario XG 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 reports are not explicitly detailed in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Toshiba American Medical Systems Inc. is recalling 477 units of the Xario XG Diagnostic Ultrasound System (model SSA-680A). 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, overheating can occur when the system is used in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. The source text indicates 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 notice. Users should stop using the affected systems in the specified modes and contact Toshiba American Medical Systems Inc. for further instructions on corrective actions.
The recalled product
- Product
- Xario XG Diagnostic Ultrasound System SSA-680A 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.
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