Recall Z-1078-06 ยท JAK System, X-Ray, Tomography, Computed
Hitachi Medical Systems America Inc
Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
| Date | Jun 3, 2006 (initiated Feb 21, 2006) |
| Status | Terminated |
| Reason | The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them. |
| Root cause | Other |
| Action | Hitachi Medical Systems America, Inc. became aware of an intermittent problem in the Multi-planar Reconstruction process when covering long ranges that could result in blank frames in the displayed reconstructions. HMSA also discovered a second software-related problem with the 50mm scale displayed on filmed images. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. Software corrections have already been installed on all units in order to correct the first of these problems (MPRs). According to the firm''s Device Notificat |
| Quantity | 15 units |
| Distribution | The recalled MRI systems were distributed throughout the continental United States. |
| FDA record | Open on fda.gov |