Recall Z-1079-06 ยท JAK System, X-Ray, Tomography, Computed
Hitachi Medical Systems America Inc
Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)
| Date | Jun 3, 2006 (initiated Feb 21, 2006) |
| Status | Terminated |
| Reason | The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized. |
| Root cause | Other |
| Action | Hitachi Medical Systems America, Inc. was informed of a software-related problem with the 50mm scale displayed on filmed images. This problem was reported to the firm by their Japanese manufacturer. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. The firm issued a Device Correctioin Notice to their customers on 2/21/2006. The notice concerns the referenced software problem which results in the resizing of the images, as well as a second previously discovered problem which results in blank multi-planer reconstructions |
| Quantity | 16 |
| Distribution | The 16 devices were distributed to 11 states: Texas, Florida, Louisiana, Illinois, Connecticut, Ohio, Massachusetts, Wisconsin, Idaho, California, New Jersey |
| FDA record | Open on fda.gov |