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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Digital Diagnost R2.0.2

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  Class 2 Device Recall Philips Digital Diagnost R2.0.2 see related information
Date Initiated by Firm October 30, 2012
Date Posted December 05, 2012
Recall Status1 Terminated 3 on January 17, 2017
Recall Number Z-0475-2013
Recall Event ID 63619
510(K)Number K982795  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Philips Digital Diagnost Software Version R2.0.2

Product Usage:
This system is used for making X-ray exposures for diagnostics
Code Information All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Beth St. Germain
978-659-4519
Manufacturer Reason
for Recall		 With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.
FDA Determined
Cause 2		 Software design
Action Philips Healthcare initiated a recall on October 25, 2012 via Urgent - Field Safety Notice for the Digital Diagnost X-ray System. The letter identified the affected product, problem and actions to be taken. The letter informs customers that Philips will supply a software update kit to version 2.1.4. For questions please contact your local Philips representative 1-800-722-9377.
Quantity in Commerce 623 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, India, Indonesia, Iraq, Italy, Japan, Latvia, Lithuania, Libya, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE 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.
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