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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 63674
Product Type Devices
Status Ongoing
Recalling Firm Philips Healthcare Inc.
City Andover
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA Nationwide and the Foreign countries of: Austria, Canada, Belgium, China,Denmark, France, germany, Italy, Netherlands,New Zealand, Norway, Philippines, Portugual, SOuth Korea, Spain, Switzerland, Thailand, and UK.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system Systems with Eleva SW version 2.1.3 Class II 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. 551 Z-0884-2013