The FDA Enforcement Report for the week of March 13, 2013, lists the ongoing recall of the Philips digital Diagnost stationary radiographic system.
Recalled on October 30, 2012 by Philips Healthcare Inc, Andover, Mass, recall number Z-0900-2013, the Class II Recall affects 360 digital Diagnost systems around the world that have Eleva software version 3.0.x.
The report lists the reason for the recall as follows: When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
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