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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Imaging

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 Class 2 Recall
Philips Imaging
see related information
Date Posted May 30, 2012
Recall Status1 Open
Recall Number Z-1689-2012
Recall Event ID 61779
Premarket Notification
510(K) Number
K042368 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.
Code Information Serial numbers: PC1-0504 through PC1 -0588.
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
Unexpected Low-level X-ray pulse
FDA Determined
Cause 2
DESIGN: Device Design
Action Philips sent a Urgent Field Safety Notice dated April 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of the communication. Please retain a copy with the equipment instruction for Use. A Philips Service Engineer will contact account as soon as the Field Action Kit is ready to be implemented. Communicate with Philips with regard to this program, please reference Field Change Order 70400049. Further questions please contact your local Philips representative at 1-800-722-9377.
Quantity in Commerce 10 US; 66 internattional
Distribution Worldwide Distribution-- USA ( nationwide ) including the states of IA, LA, LA, ND, NY, OH and TX and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Germany, Hong Kong, Indonesia, Italy, Malaysia, Mexico, Netherlands, Philippines, Qatar, Russia, Saudi Arabia, Singapore, South Africa,Thailand and Ukraine.
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 = IZL and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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