Toshiba Recalls Aquilion Lightning CT System iStation Cover
Toshiba American Medical Systems is recalling the Aquilion Lightning CT System iStation cover because it may fall off the gantry.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a component falling off, which poses a risk of injury, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
Toshiba American Medical Systems, Inc. is recalling the Aquilion Lightning CT System iStation cover (Item Code: TSX-0354A/2D.03, SID: 70000246). The recall is due to a potential problem where the cover may fall off of the gantry.
The affected unit is identified by Serial No. 2DA15Y2036. The product was distributed in the state of Nevada. The Aquilion Lightning is a multislice helical CT system used for whole-body imaging.
Consumers and healthcare facilities should contact Toshiba American Medical Systems for instructions on how to address the issue.
The recalled product
- Product
- Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast…
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 1
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)
- Serial No. 2DA15Y2036
Distribution
Distributed in 1 state:
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