Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating Risk
Toshiba is recalling 17 diagnostic ultrasound systems because the transducer head may overheat under specific operating modes, posing a burn risk to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (thermal injury/burn) where the source text does not explicitly state that injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
Toshiba American Medical Systems Inc. is recalling 17 units of the Xario Diagnostic Ultrasound System SSA-660A. These devices are used for routine diagnostic imaging and were distributed nationwide, including in the U.S. territory of Puerto Rico.
The recall was initiated because the transducer head may increase in temperature under certain conditions. Specifically, overheating can occur when the system is used in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. This temperature increase presents a potential risk of thermal injury to patients.
Healthcare facilities and users of these specific serial numbers should stop using the affected systems and contact Toshiba American Medical Systems Inc. for further instructions on corrective actions.
The recalled product
- Product
- Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
- Manufacturer
- Toshiba American Medical Systems Inc
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
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