Hitachi Scenaria CT System Recalled for Table Motion Hazard
Hitachi is recalling one Scenaria CT system in Texas because the patient table failed to stop and contacted the gantry, posing a risk of injury.
What this means for you
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 involves a risk-of-harm product where injury has not yet been reported, which corresponds to a score of 3 (High) per the rubric.
Plain-English summary
Hitachi Medical Systems America Inc is recalling one unit of the Hitachi Scenaria CT system. The recall was initiated after a complaint reported that the patient table failed to stop when the control was released during positioning, causing the table to contact the CT gantry.
The problem could not be duplicated at the site, but Hitachi is adding an optional touch sensor to the gantry to provide a redundant level of protection. The source notes that a patient's extremity could be caught between the tabletop and the gantry surface during uncontrolled motion, or that the contact might cause internal damage to the unit.
The affected unit was distributed to one customer in Texas. Consumers and healthcare facilities should contact Hitachi Medical Systems America Inc for further instructions regarding the installation of the safety sensor.
The recalled product
- Product
- Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume dat
- Manufacturer
- Hitachi Medical Systems America Inc
- 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)
- S7004
Distribution
Distributed in 1 state:
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