Toshiba Aquilion CT System Recalled for Data Loss Risk
Toshiba American Medical Systems is recalling 459 Aquilion CT Systems because specific scanning operations may cause raw data to not be saved.
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 does not report any injuries, illnesses, or hospitalizations. The hazard is a data integrity issue rather than a direct physical safety risk, fitting the criteria for a moderate severity score.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 459 units of the Toshiba Aquilion CT System TSX-301B. The recall affects systems running software version 6.0 or later. These devices were distributed throughout the United States, including Puerto Rico.
The recall is due to a software issue where acquired raw data may not be saved if two specific operations are performed during multi-phase helical scanning. This defect could result in the loss of diagnostic data.
Healthcare facilities using these systems should contact Toshiba American Medical Systems for instructions on how to resolve the issue.
The recalled product
- Product
- Toshiba Aquilion CT System TSX-301B
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 459
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)
- system software V6.0 or later
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 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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