Recall Z-1651-2009 ยท JAK System, X-Ray, Tomography, Computed
Hitachi Medical Systems America Inc
Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
| Date | Jul 7, 2009 (initiated Apr 14, 2009) |
| Status | Terminated |
| Reason | Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect. |
| Root cause | Software design |
| Action | HMSA issued an URGENT - DEVICE CORRECTION notification to their customers on 4/14/2009. The notification describes the potential software error and the condition under which these image distortions can occur. The notification goes on to provide the customer with a work-around procedure which they can use to avoid encountering this issue with their current software configuration(s). The letter states that the firm will be installing updated software on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting each customer and making arrangements to com |
| Quantity | 47 units |
| Distribution | Nationwide distribution, including Puerto Rico (PR). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040902 | HITACHI PRESTO Hitachi Medical Systems America, Inc., Apr 21, 2004 |