Recall Z-1541-2017— Hitachi Medical Systems America Inc
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 3 FDA 510(k) clearances: K153547, K151015, K113145. Product: Hitachi Echelon Oval 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
3 on FDA's record- K153547 — ECHELON Oval V 5.1 MRI System
- K151015 — ECHELON Oval V 5.0 MRI System
- K113145 — ECHELON OVAL MRI SYSTEM
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 Echelon Oval 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.