FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
- Recall number
- Z-1078-06
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
- Status
- Terminated
- Initiated
- 2006-02-21
- Posted
- 2006-06-03
- Terminated
- 2008-11-13
- Reason
- The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them.
- Root cause
- Other
- Action
- Hitachi Medical Systems America, Inc. became aware of an intermittent problem in the Multi-planar Reconstruction process when covering long ranges that could result in blank frames in the displayed reconstructions. HMSA also discovered a second software-related problem with the 50mm scale displayed on filmed images. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. Software corrections have already been installed on all units in order to correct the first of these problems (MPRs). According to the firm''s Device Notification Letter issued on 2/21/2006, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006 and this correction will be performed by HMSA''s service personnel during each customer''s next scheduled PM. The Device Notification Letter also instructs the customers to call their Field Service Representatives or the HMSA Applications Helpline if they have any questions about the notice, or if any additional problems are encountered.
- Quantity
- 15 units
- Distribution
- The recalled MRI systems were distributed throughout the continental United States.
- Lot, serial or model codes
- Serial Number: CXR46201-46213 PC 46002-36011
- 510(k) numbers
- ["K040902","K042428"]
- 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