Toshiba Aquilion CT System Recall for Data Loss Risk
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being 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. The hazard involves potential data loss during specific scanning operations, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate severity criteria for low-risk functional issues.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 459 units of the Toshiba Aquilion CT System TSX-101A. The recall involves systems running software version 6.0 or later that were distributed in the United States, including Puerto Rico.
The recall is issued because if two specific operations are performed during multi-phase helical scanning, the acquired raw data may not be saved. This issue affects the integrity of the data acquired during these specific scanning procedures.
Healthcare facilities using these systems should contact Toshiba American Medical Systems Inc for further instructions on how to address the software issue.
The recalled product
- Product
- Toshiba Aquilion CT System TSX-101A
- 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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