Recall Z-1541-2017 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
Hitachi Echelon Oval MRI System
| Date | Mar 23, 2017 (initiated Apr 16, 2015) |
| Status | Terminated |
| Reason | Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. |
| Root cause | Software in the Use Environment |
| Action | Formal notification letters were sent to consignees on 2/13/17. Hitachi Service will update the software at each site during visits. |
| Quantity | 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, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are four (4) gove |
| FDA record | Open on fda.gov |