Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less.

FDA device recall Z-1652-2009 · posted 2009-07-07 · Terminated

Recall details

Recalling firm

Hitachi Medical Systems America Inc

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

4 units

Distribution

Nationwide distribution, including Puerto Rico (PR).

Date initiated

2009-04-14

Date posted

2009-07-07

Date terminated

2012-09-21

Location

Twinsburg, OH

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