FDA Device

Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.

Hazard

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.

What You Should Do

Remedy

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.

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Products

Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
Brand
Hitachi Medical Systems America Inc
UPC
The recalled CXR4 system units are identified with the following Code Numbers: CXR46201 through CXR4622 and CXR4624 through CXR46244.

Units Affected

47 units

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