Z-2392-2016 Class II Terminated
FDA device recall Z-2392-2016 was initiated by Hitachi Medical Systems America Inc on June 30, 2015 and is designated Class II. 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 r… The recall status is terminated (terminated November 1, 2016). Affected quantity: 33 units.
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