Recall Z-1540-2017— Hitachi Medical Systems America Inc

Name: FDA recall Z-1540-2017
Creator: U.S. Food and Drug Administration
Published: 2015-04-16

Class II · Terminated

Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2015-04-16, terminated 2017-06-29. It names one FDA 510(k) clearance: K153547. Product: Hitachi Oasis MRI System. Reason: Image data transferred from the MRI system to a workstation showed errors on the slice position reference image..

Recalling firm: Hitachi Medical Systems America Inc
Classification: Class II
Status: Terminated
Initiated: 2015-04-16
Terminated: 2017-06-29
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K153547 — ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc.·cleared 2016-03-31

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 Oasis MRI System

Reason for recall

Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

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