Hitachi Scenaria CT System Software Product Usage: The recall: Software Issue
Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The…
Why was Hitachi Scenaria CT System Software Product Usage: The recalled?
Hitachi discovered 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 changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial #'s S5001 - S5011
- 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…
- Recalling firm
- Hitachi Medical Systems America Inc
- Quantity
- Six (6) units
- Distribution
- US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
- Recall date
- July 25, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)