Class 2 Device Recall Philips Volcano Core M2Imaging Systems

• Date Initiated by Firm: March 22, 2018
• Date Posted: May 17, 2018
• Recall Status: Terminated on April 28, 2021
• Recall Number: Z-1891-2018
• Recall Event ID: 79715
• 510(K)Number: K172455
• Product Classification: System, imaging, pulsed echo, ultrasonic - Product Code IYO
• Product: Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
• Code Information: Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077.
• Recalling Firm/ Manufacturer: Volcano Corporation; 2870 Kilgore Rd; Rancho Cordova CA 95670-6133
• For Additional Information Contact: Melissa Pieplow; 800-228-4728
• Manufacturer Reason for Recall: The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
• FDA Determined Cause: Other
• Action: Customers were notified on 03/21/2018. U.S. customers were notified via hand-delivered Urgent Medical Device Recall letters; foreign customer letter was mailed. The letter identified the affected device and the reason for the recall. Instructions included to stop usage of the device and to call remote support at 1-800-228-4728, to schedule a visit to replace the affected device. Customers were instructed to complete and return the customer response form or to provide the form to Philips representatives. Customers were also instructed to provide copies of the recall notification to all personnel within their organization who handled this device.
• Quantity in Commerce: 8 devices
• Distribution: Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
• 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 = IYO