Toshiba XARIO 200 Ultrasound System Recalled for Incorrect Velocity Trace Values
Toshiba American Medical Systems is recalling XARIO 200 diagnostic ultrasound systems because the Continuous Trace method may display incorrect velocity trace values.
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 high-risk medical device where a software defect could lead to incorrect diagnostic values, representing a risk of harm even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Toshiba American Medical Systems Inc is recalling one unit of the XARIO 200 TUS-X200 diagnostic ultrasound system, identified by serial number W5B1712472. The device was distributed nationwide.
The recall is issued because when the Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound system and associated workstations. This software defect could lead to inaccurate diagnostic data.
Healthcare providers and consumers with this specific serial number should contact Toshiba American Medical Systems for further instructions on how to resolve the issue.
The recalled product
- Product
- XARIO 200 TUS-X200 diagnostic ultrasound system
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number W5B1712472
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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