Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating
Toshiba is recalling 430 diagnostic ultrasound systems because the transducer head may overheat under specific operating conditions.
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 (potential burn injury from overheating) where specific injury reports are not explicitly detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without confirmed reported injuries.
Plain-English summary
Toshiba American Medical Systems Inc. is recalling 430 units of the Aplio XG Diagnostic Ultrasound System SSA-790A. These systems 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, the issue occurs 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 the specific injury type is not fully detailed in the provided excerpt.
Healthcare facilities and users should check their serial numbers against the list provided in the official recall notice to determine if their equipment is affected. Toshiba is the recalling firm responsible for addressing this defect.
The recalled product
- Product
- Aplio XG Diagnostic Ultrasound System SSA-790A 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
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