ECLOS Computed Tomography XRay System 의 리콜

Recall

52430

Class 2

Z-1652-2009

2009-04-14

2009-07-07

Terminated

United States

2012-09-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82973

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.

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.