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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Digital Diagnost

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  Class 2 Device Recall Philips Digital Diagnost see related information
Date Initiated by Firm October 25, 2012
Date Posting Updated February 26, 2013
Recall Status1 Terminated 3 on March 31, 2014
Recall Number Z-0884-2013
Recall Event ID 63674
510(K)Number K982795  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3
Model numbers 712020, 712022, and 712082

Product Usage:

Digital radiographic system
Code Information Systems with Eleva SW version 2.1.3
Recalling Firm/
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Beth St. Germain
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
Action Philips Medical Systems issued on October 25, 2012 an Urgent Field Safety Notice for the Digital Diagnost System informing consignees of the software upgrade. The UFSN described the problem, the hazard involved, the action to be taken by the consumer/user and the action planned by Philips. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.
Quantity in Commerce 551
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.