Recall Z-2564-2014— Hitachi Medical Systems America Inc
Class II · Terminated
Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2014-08-18, terminated 2015-09-14. It names one FDA 510(k) clearance: K113145. Product: Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.. Reason: The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard..
- Recalling firm
- Hitachi Medical Systems America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-18
- Terminated
- 2015-09-14
- Firm location
- Twinsburg, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
Reason for recall
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Data sourced from openFDA. This site is unofficial and independent of the FDA.