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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Spectral CT Applications with software version 6.5

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  Class 2 Device Recall Philips Spectral CT Applications with software version 6.5 see related information
Date Initiated by Firm November 14, 2016
Create Date July 02, 2018
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-0706-2017
Recall Event ID 75755
510(K)Number K150665  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.
Code Information 50001 50002 50004 50005 50006 50008 50009 50100 50101 50102 50103 430000 430001 430002 430003 430004 430006 430007 430501 430502
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Ms. Holly Lee Wright
440-483-2015
Manufacturer Reason
for Recall		 A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
FDA Determined
Cause 2		 Software design
Action A Field Safety Notice (Attachment #1 Field Safety Notice FSN 16-061-72800659 and FSN 88100051), will be sent to US consignees via certified mail. Philips Key Market representatives will distribute the notice internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.
Quantity in Commerce 20
Distribution Software was distributed in the following states: AR, IN, LA, MA, MN, OR and TN. Softward was also shipped to the following countries: Belgium, Denmark, France, Germany, Japan, Korea, Switzerland and United Kingdom.
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 = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS NETHRLANDS BV
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