Hitachi Medical Systems America Inc Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
The recalled CXR4 system units are identified with the following Code Numbers: CXR46201 through CXR4622 and CXR4624 through CXR46244.
Hitachi Medical Systems America Inc is recalling Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less. due to 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-Recon. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026