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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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