Toshiba Recalls Xario Ultrasound Systems Due to Overheating Software Error
Toshiba American Medical Systems is recalling 93 Xario 100 and 200 Diagnostic Ultrasound Systems because a software error may cause the devices to become hot.
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 (overheating medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 93 units of the Xario 100 (TUS-X100) and Xario 200 (TUS-X200) Diagnostic Ultrasound Systems. The recall is being conducted because a software error may cause the devices to become hot.
The affected units were distributed in the United States. The recall covers specific serial numbers listed in the official FDA record Z-2542-2016.
Healthcare facilities and users should stop using the affected units and contact Toshiba American Medical Systems for further instructions on the recall.
The recalled product
- Product
- Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 93
Distribution
Distribution scope not specified by the agency.
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