Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
This recall has been terminated (originally issued June 30, 2015).
- Recall Initiated
- June 30, 2015
- Terminated
- November 1, 2016
- Recall Number
- Z-2392-2016
- Quantity
- 33 units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Serial #'s: S5002-S5014; S5017-S5038
Root Cause
Component design/selection
Action Taken
Hitachi sent an Device Correction Notice dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were informed that there is a problem with the Hitachi Medical Systems America, Inc.CT system; the issue is with a power supply in the CT gantry sub-system. During fast rotation (i.e., 35 sec), the centrifugal force applied to the power supply may cause it to fail over time. For further questions, please call (330) 425-1313 ext. 3720.