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U.S. Department of Health and Human Services

Class 2 Device Recall MobileDiagnost wDR

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  Class 2 Device Recall MobileDiagnost wDR see related information
Date Initiated by Firm November 28, 2012
Create Date April 04, 2017
Recall Status1 Terminated 3 on May 31, 2018
Recall Number Z-1706-2017
Recall Event ID 64902
510(K)Number K111725  
Product Classification System, x-ray, mobile - Product Code IZL
Product Mobile Diagnostic X-Ray System with Digital Panel
Code Information *** All units ***
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Mr. Dominic Siewko
800-722-9377
Manufacturer Reason
for Recall
When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.
FDA Determined
Cause 2
Software design
Action Philips Medicals Systems distributed an "URGENT Field Safety Notice" alerting customers of the defect on November 28, 2012. Customers are requested to manually rotate images by using the rotation tool.Customers are also recommended to check whether the automatic marker is set correctly, especially after a manual image rotation is performed. The marker can be corrected manually with the annotation tool.
Quantity in Commerce 220 systems
Distribution Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
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 = IZL and Original Applicant = SEDECAL SA
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