Hitachi Scenaria CT System Software Recall for Reconstruction Error
Hitachi is recalling Scenaria CT System software due to a defect that may cause incomplete image reconstruction, potentially resulting in missing diagnostic data.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (missing diagnostic data) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Hitachi Medical Systems America Inc is recalling six units of the Scenaria CT System software. The recall is due to a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed.
When multiple reconstructions are queued for processing, if a queue is suspended and the task order is changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data. The affected units have serial numbers S5001 through S5011.
The affected units were distributed nationwide to the states of Maryland, Michigan, Mexico, North Dakota, New York, Ohio, and Texas. The source text does not specify instructions for consumers or healthcare providers regarding the recall.
The recalled product
- Product
- Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be…
- Manufacturer
- Hitachi Medical Systems America Inc
- Affected units
- 6
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 #'s S5001 - S5011
Distribution
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