Class 2 Device Recall MobileDiagnost wDR

• Date Initiated by Firm: November 28, 2012
• Create Date: April 04, 2017
• Recall Status: Terminated 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: 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