Recall Z-1534-2010 ยท IWE Monitor, Patient Position, Light-Beam
Hitachi Medical Systems America Inc
Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
| Date | May 4, 2010 (initiated Sep 1, 2009) |
| Status | Terminated |
| Reason | The device has a software error that could potentially lead to a misdiagnosis. |
| Root cause | Software design (manufacturing process) |
| Action | Sites have already been corrected. Software updated from V1.0C to V2.0B |
| Quantity | 43 |
| Distribution | Nationwide distribution: AZ, CA, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, MO, NC, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, WI, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072279 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc., Sep 21, 2007 |