Recall Z-0029-2007 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
| Date | Oct 12, 2006 (initiated Aug 16, 2006) |
| Status | Terminated |
| Reason | Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate. |
| Root cause | Other |
| Action | On 8/16/2006, Hitachi issued two (2) Device Correction letters. The first letter was addressed to the five (5) customers whose system units are currently ''de-installed''. This letter informs the customers of the problem and asks that the customer(s) please contact the firm''s Customer Service Center on their toll-free tel. # 1-800-800-4925, in order to schedule a device correction should the customer ever re-activate/install their system(s). The second letter, issued to the customers with activated MRP-7000 and/or AIRIS MRI systems, informs the customers of the problem, and states that a H |
| Quantity | 348 units |
| Distribution | Nationwide and Puerto Rico. |
| FDA record | Open on fda.gov |