Z-2392-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 17, 2016
- Initiation Date
- June 30, 2015
- Termination Date
- November 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units
Product Description
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Reason for Recall
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.
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.
Code Information
Serial #'s: S5002-S5014; S5017-S5038