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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Diagnost

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 Class 2 Recall
Digital Diagnost
see related information
Date Posted April 26, 2012
Recall Status1 Terminated on March 13, 2014
Recall Number Z-1464-2012
Recall Event ID 61528
Premarket Notification
510(K) Number
K982795 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital
Code Information Model #s 712020, 712022, 712082 All systems with Eleva software version 2.x and stitching option.
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
For Additional Information Contact Dominic Siewko
978-687-1501
Manufacturer Reason
for Recall
Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action The firm, Philips Healthcare Imaging, issued an "URGENT-FIELD SAFETY NOTICE" dated March 30, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions carefully and to not use the Philips Image Ruler for measurements. The firm plans to supply an Addendum to the Instructions For Use and a Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented. If you need any further information or support concerning this issue, please contact your local Philips representative or call 1-866-767-2822.
Quantity in Commerce 606 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech. Rep, Denmark, Finland, France, Germany, Guadeloupe, India, Indonesia, Iran, Iraq, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Salkowski, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ver.Arab.Emir.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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