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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Diagnost

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 Class 2 Device Recall Digital Diagnostsee related information
Date Initiated by FirmApril 03, 2012
Date PostedApril 26, 2012
Recall Status1 Terminated 3 on March 13, 2014
Recall NumberZ-1464-2012
Recall Event ID 61528
510(K)NumberK982795 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductPhilips 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. 
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information ContactDominic Siewko
978-687-1501
Manufacturer Reason
for Recall		Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
FDA Determined
Cause 2		Labeling design
ActionThe 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 Commerce606 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = MQB
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