FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
- Recall number
- Z-1651-2009
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
- Status
- Terminated
- Initiated
- 2009-04-14
- Posted
- 2009-07-07
- Terminated
- 2012-09-21
- 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 come out and install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, which the customer can use to obtain additional information, if desired.
- Quantity
- 47 units
- Distribution
- Nationwide distribution, including Puerto Rico (PR).
- Lot, serial or model codes
- The recalled CXR4 system units are identified with the following Code Numbers: CXR46201 through CXR4622 and CXR4624 through CXR46244.
- 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