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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Ingenuity TF PET/CT Imaging Systems

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  Class 2 Device Recall Philips Ingenuity TF PET/CT Imaging Systems see related information
Date Initiated by Firm February 15, 2018
Create Date April 17, 2018
Recall Status1 Terminated 3 on November 21, 2019
Recall Number Z-1392-2018
Recall Event ID 79696
510(K)Number K052640  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Ingenuity TF PET/CT, Model No. 882442

Product Usage:
The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.
Code Information Serial No: 2090 2072 2077 2079 2086 2091 2093 2085 2076 2071 2078 2081 
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Ms. Holly Wright Lee
440-483-5777
Manufacturer Reason
for Recall		 Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
FDA Determined
Cause 2		 Under Investigation by firm
Action On February 15, 2018, the recalling firm notified customers of the recall via letter. The notice stated that to avoid the hazard of performing a rescan or reinjection, all users must be informed not to view studies or access data on the Addonics MSD while a patient is being scanned. If a user is attempting to view information stored on the Addonics MSD and the console appears to be unresponsive, reset power on the Addonics MSD or pull out and reconnect its USB cable. It is recommended that the Addonics USB Mass Storage Device be turned off when not being accessed, and powered on only when data transfer is needed. Following data transfer, the Addonics USB Mass Storage Device should be turned off. Customers were instructed to inform those who need to be aware within their organization or any organization wehre potentially affected devices have been transferred; transfer the notice to other affected organizations; and maintain the recall notice with their system Instructions For Use until the correction is made to the system. Customers were advised that Philips will be providing an updated Mass Storage Device that does not experience the same issue that will be provided at no additional cost to the customer. The Field Correction will be released in Q1 2018. Customers who need further information or support regarding the recall were directed to contact their local Philips representative. Customer Care Solutions Center: 1-800-722-9377.
Quantity in Commerce 12
Distribution Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.
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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