Hitachi Medical Systems America Inc: Medical Device Recall in 2016 - (Recall #: Z-2392-2016)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2016.
Data Source: FDA.
Product Description:
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Product Classification:
Class II
Date Initiated: June 30, 2015
Date Posted: August 17, 2016
Recall Number: Z-2392-2016
Event ID: 74714
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.
Status: Terminated
Product Quantity: 33 units
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.
Voluntary or Mandated:
Voluntary: Firm initiated