Hitachi Scenaria CT System Recalled for Power Supply Failure Risk
Hitachi Medical Systems America is recalling 33 Scenaria CT systems because centrifugal force may cause the power supply to fail, potentially requiring patients to be rescanned.
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, but the source text explicitly states no injuries or illnesses have been reported. The hazard is a functional failure leading to a rescan, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hitachi Medical Systems America Inc is recalling 33 units of the Hitachi Scenaria Computed Tomography System. The recall was initiated after the firm discovered that the centrifugal force applied to the power supply may cause it to fail over time.
The affected units were distributed in the United States to California, Florida, Georgia, Iowa, Illinois, Indiana, Maryland, North Carolina, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, and Wyoming, as well as internationally to Brazil and Mexico. The specific serial numbers affected are S5002-S5014 and S5017-S5038.
If a power supply failure occurs, the exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
- Manufacturer
- Hitachi Medical Systems America Inc
- Hazard
- Affected units
- 33
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 (2)
- Serial #'s: S5002-S5014
- S5017-S5038
Distribution
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