Toshiba Aquilion CT System Recall for Data Loss Risk
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may cause acquired 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 hazard is a software data loss issue rather than a direct physical injury or contamination, fitting the 'Moderate' criteria for low-risk or theoretical harm without reported injuries.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 459 units of the Toshiba Aquilion CT System TSX-303A. The recall involves systems running software version V5.00 - R000 or later. These units were distributed in the United States, including Puerto Rico.
The recall is issued because if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. This is a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Healthcare facilities and users of these CT systems should contact Toshiba American Medical Systems Inc for further instructions on how to address the potential data loss issue. No specific corrective action or replacement details are provided in the source text.
The recalled product
- Product
- Toshiba Aquilion CT System TSX-303A
- 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 V5.00 - R000 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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