Recall Z-0608-2009 ยท JAK System, X-Ray, Tomography, Computed
Hitachi Medical Systems America Inc
Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.
| Date | Jan 8, 2009 (initiated Nov 5, 2008) |
| Status | Terminated |
| Reason | Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal). |
| Root cause | Software design |
| Action | On 11/5/2008 Hitachi Medical Systems sent recall notification letters entitled "URGENT - DEVICE RECALL CORRECTION" to its customers informing them of the problem with the software. They stated that a Hitachi service representative will contact each customer to schedule a software upgrade. For further information, please contact Hitachi Medical Systems America Inc. by telephone at 330-425-1313. |
| Quantity | 42 |
| Distribution | Nationwide Distribution --- including states of AZ, CA, DE, FL, ID, IL, IN, KS, KY, LA, MA, MO, NJ, NY, OH, OK, PA, PR, SC, TX, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040902 | HITACHI PRESTO Hitachi Medical Systems America, Inc., Apr 21, 2004 |