Toshiba APLIO 300 Ultrasound Systems Recalled for Incorrect Velocity Trace Display
Toshiba is recalling 90 APLIO 300 diagnostic ultrasound systems because they may display incorrect velocity trace values when using the Continuous Trace method.
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 is classified as FDA Class II, which typically corresponds to a High severity score (3) when no hospitalizations or serious injuries are reported, as the hazard involves incorrect data display rather than direct physical harm.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 90 units of the APLIO 300 TUS-A300 diagnostic ultrasound system. The recall is due to a software issue where the system may display an incorrect value in the velocity trace measurement when the Continuous Trace method is used as the tracing method on Spectral Doppler.
The affected units were distributed nationwide. The recall includes specific serial numbers listed in the agency's documentation. The issue affects both the ultrasound systems and the associated ultrasound workstations.
Healthcare providers should contact Toshiba American Medical Systems Inc for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- APLIO 300 TUS-A300 diagnostic ultrasound system
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 90
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 (20)
- Serial Numbers: AAC1692086
- AAC1692087
- AAC1692088
- AAC1692089
- AAC1692090
- AAC16Y2091
- AAC16Y2092
- AAC16Y2093
- AAC16Y2094
- AAC16Y2095
- AAC16Y2096
- AAC16Y2097
- AAC16Y2098
- AAC16Y2099
- AAC16Y2100
- AAD16Z2101
- AAD16Z2102
- AAD16Z2103
- AAD16Z2104
- AAD16Z2105
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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