Recall Z-0797-05 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
Altaire, Magnetic Resonance Imaging Device.
| Date | May 3, 2005 (initiated Apr 11, 2005) |
| Status | Terminated |
| Reason | The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard. |
| Root cause | Other |
| Action | The firm sent a recall/field correction letter, dated 4/11/05, to direct accounts. |
| Quantity | 212 devices |
| Distribution | Direct accounts located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. |
| FDA record | Open on fda.gov |