Toshiba XARIO 100 Ultrasound Systems Recalled for Incorrect Velocity Readings
Toshiba American Medical Systems is recalling seven XARIO 100 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method for velocity measurements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software measurement error without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Toshiba American Medical Systems Inc. is recalling seven units of the XARIO 100 TUS-X100 diagnostic ultrasound system. The recall was initiated because the devices may display incorrect values in the ultrasound systems and associated workstations when the Continuous Trace method is used for velocity trace measurement in Spectral Doppler.
The affected units were distributed nationwide. The specific serial numbers for the recalled units are W5B16Z2555, W5B1712642, MXA1723100, MXA1723098, MXA1723101, MXA1723099, and MXA1723097.
Healthcare providers and users should check their equipment serial numbers against the list provided by the manufacturer. If a unit is affected, users should contact Toshiba American Medical Systems Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- XARIO 100 TUS-X100 diagnostic ultrasound system
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 7
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 (7)
- Serial Numbers: W5B16Z2555
- W5B1712642
- MXA1723100
- MXA1723098
- MXA1723101
- MXA1723099
- MXA1723097
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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