Company:Philips Healthcare Inc.
Date of Enforcement Report 3/6/2013
Class ll:
PRODUCT
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
Recall Number Z-0884-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA on 10/25/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
551
DISTRIBUTION
Nationwide and Internationally
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