Device product
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Z-2392-2016
Product summary
- Event
- Event 74714
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 units
- Official record key
device-enforcement:Z-2392-2016
Official wording
Reason: The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.
Code information: Serial #'s: S5002-S5014; S5017-S5038
Distribution pattern: US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
Derived failure modes
-
Unknown
The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.