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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Ingenuity TF PET/CT

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  Class 2 Device Recall Philips Healthcare Ingenuity TF PET/CT see related information
Date Initiated by Firm November 01, 2017
Create Date February 04, 2018
Recall Status1 Terminated 3 on August 14, 2018
Recall Number Z-0522-2018
Recall Event ID 79004
510(K)Number K052640  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Code Information Ingenuity TF PET/CT Model # 882442 
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
440-483-5777
Manufacturer Reason
for Recall		 One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
FDA Determined
Cause 2		 Vendor change control
Action Philips Healthcare is notifying the affected users of this issue via this Customer Information Letter and correcting via Field Change Order FC088200514.
Quantity in Commerce 2
Distribution One domestic and 1 foreign consignee ( Spain)
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 = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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