Date Initiated by Firm | November 14, 2016 |
Create Date | July 02, 2018 |
Recall Status1 |
Terminated 3 on July 02, 2018 |
Recall Number | Z-0705-2017 |
Recall Event ID |
75755 |
510(K)Number | K133674 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. |
Code Information |
860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860028 860026 860029 860030 860031 860034 860035 |
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 | 24 |
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
|