The FDA announced on June 29, 2018, that Hitachi Medical Systems America Inc. recalled one Hitachi Scenaria CT system due to a patient table failure hazard. The agency classified the recall as Class II.
How to tell if you have it
- Brand: Hitachi
- Product: Hitachi Scenaria CT system
- Distribution: One unit sold to a customer in TX
The hazard
During patient positioning, the technologist was adjusting the table height when it failed to stop upon release and contacted the CT gantry. This uncontrolled motion could cause a patient's extremity to be caught or damage the unit internally.
Context
GovInfoNow's records show Hitachi Medical Systems America Inc. has issued five other recalls since October 20, 2017. Other recent recalls of similar products include the Hitachi Scenaria X-ray CT System Recall (2019-10-16) and the Hitachi Medical Ultrasonic Doppler System Software Error Risk (2021-03-01). Recent industry recalls include the Philips Azurion 5 M12 System Software Recalls (2026-01-26) and the Hitachi Proton Beam Therapy System Recall (2026-02-06).