Recall Z-2392-2016— Hitachi Medical Systems America Inc

Name: FDA recall Z-2392-2016
Creator: U.S. Food and Drug Administration
Published: 2015-06-30

Class II · Terminated

Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2015-06-30, terminated 2016-11-01. It names one FDA 510(k) clearance: K101888. Product: Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087. 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..

Recalling firm: Hitachi Medical Systems America Inc
Classification: Class II
Status: Terminated
Initiated: 2015-06-30
Terminated: 2016-11-01
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K101888 — SCENARIA WHOLE-BODY X-RAY CT SYSTEMHitachi Medical Systems America, Inc.·cleared 2011-04-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.