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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity TF PET/MR

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  Class 2 Device Recall Ingenuity TF PET/MR see related information
Date Initiated by Firm March 11, 2015
Date Posted May 28, 2015
Recall Status1 Terminated 3 on June 26, 2018
Recall Number Z-1682-2015
Recall Event ID 71228
510(K)Number K103483  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems.

The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
Code Information Serial #'s: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mr. Yuchol Kim
440-483-2997
Manufacturer Reason
for Recall		 It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data.
FDA Determined
Cause 2		 Software in the Use Environment
Action On 3/11/2015 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected device, explained the reason for the recall, how to identify affected product, advice on actions to be taken by customer/user, and any actions planned by the firm. Customers were advised to use software provided by Philips to view spectroscopy images; and, not to export and view images using third party software. The firm stated that it will be issuing a software update. If further information or support concerning the issue is needed, customers are asked to contact their local Philips representative or local Philips Healthcare office.
Quantity in Commerce 10 units
Distribution Worldwide Distribution -- US, including the states of NY, OH, & TX; and, the countries of Finland, Germany, Japan, Netherlands, South Korea, Spain, & Switzerland.
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 HEALTHCARE (CLEVELAND)
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