Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images o
FDA device recall Z-0608-2009 · posted 2009-01-08 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2008-11-05
- Date posted
- 2009-01-08
- Date terminated
- 2012-09-21
- Location
- Twinsburg, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HITACHI PRESTO (K040902) | Hitachi Medical Systems America, Inc. | 2004-04-21 |