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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 30, 2012
Date Posting Updated March 01, 2013
Recall Status1 Terminated 3 on July 29, 2013
Recall Number Z-0900-2013
Recall Event ID 63671
510(K)Number K982795  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Philips Digital Diagnost

Stationary radiographic system
Code Information All Digital Diagnost systems with Eleva software version 3.0.x
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 Healthcare issued an Urgent Field Safety Notice dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review the information contained in the Notice with all member of their staff who need to be aware of the contents. Also, customers were asked to retain a copy with the equipment Instruction for Use. For further information or questions customers were instructed to contact their local Phillips representative Technical Support Line at 1-800-722-9377. For questions regarding this recall call 978-659-4519.
Quantity in Commerce 360
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the 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.