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U.S. Department of Health and Human Services

Class 2 Device Recall Integris Allura Radiograph / Fluoroscopy x ray system

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  Class 2 Device Recall Integris Allura Radiograph / Fluoroscopy x ray system see related information
Date Initiated by Firm August 08, 2014
Date Posted October 09, 2014
Recall Status1 Terminated 3 on December 03, 2014
Recall Number Z-0022-2015
Recall Event ID 69197
510(K)Number K002016  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Code Information Model Number: Integris Allura 15-12 Serial Number: 16741023
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips Healthcare discovered through field service testing, that the device was in violation. Firm service rep. visited site on 7/01/14 and corrected unit. The field service engineer immediately reprogrammed the generator for the X-ray tube installed in the system and re-adapted the x-ray tube to bring the system back into compliance. At this time the Failure to comply has been corrected and the customer has been notified. This correction is to be free of charge to the customer. For further questions please call (978) 687-1501.
Quantity in Commerce one system
Distribution US distribution to FL
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 = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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