FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0608-2009
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-11-05
- Posted
- 2009-01-08
- Terminated
- 2012-09-21
- 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.
- Lot, serial or model codes
- Serial numbers: CXR46202 through CXR46248 excluding CXR46207, CXR46208, CXR46215, and CXR46222.
- 510(k) numbers
- ["K040902"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28