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Class 2 Device Recall Digital Diagnost |
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Date Initiated by Firm |
April 03, 2012 |
Date Posted |
April 26, 2012 |
Recall Status1 |
Terminated 3 on March 13, 2014 |
Recall Number |
Z-1464-2012 |
Recall Event ID |
61528 |
510(K)Number |
K982795
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Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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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 MA 01810
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For Additional Information Contact |
Dominic Siewko 978-687-1501
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Manufacturer Reason for Recall |
Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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