Recall Z-1096-2017— Hitachi Medical Systems America Inc

Name: FDA recall Z-1096-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-06

Class II · Terminated

Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2017-01-06, terminated 2018-11-08. It names one FDA 510(k) clearance: K072279. Product: Hitachi Oasis MRI System - C-Spine Coil. Reason: The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam..

Recalling firm: Hitachi Medical Systems America Inc
Classification: Class II
Status: Terminated
Initiated: 2017-01-06
Terminated: 2018-11-08
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K072279 — MAGNETIC RESONANCE DIAGNOSTIC DEVICEHitachi Medical Systems America, Inc.·cleared 2007-09-21

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 - C-Spine Coil

Reason for recall

The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.

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