Hitachi Echelon Oval MRI System
FDA device recall Z-1541-2017 · posted 2017-03-23 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
- Action taken
- Formal notification letters were sent to consignees on 2/13/17. Hitachi Service will update the software at each site during visits.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 25 units
- Distribution
- US nationwide distribution. The products were distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, N
- Date initiated
- 2015-04-16
- Date posted
- 2017-03-23
- Date terminated
- 2017-06-29
- Location
- Twinsburg, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECHELON Oval V 5.1 MRI System (K153547) | Hitachi Medical Systems America, Inc. | 2016-03-31 |
| ECHELON Oval V 5.0 MRI System (K151015) | Hitachi Medical Systems America, Inc. | 2015-07-29 |
| ECHELON OVAL MRI SYSTEM (K113145) | Hitachi Medical Systems America, Inc. | 2012-05-01 |