Class 2 Device Recall INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100

• Date Initiated by Firm: December 07, 2009
• Date Posted: February 19, 2010
• Recall Status: Terminated on September 19, 2012
• Recall Number: Z-0780-2010
• Recall Event ID: 53989
• 510(K)Number: K003853
• Product Classification: system, nuclear magnetic resonance imaging - Product Code LNH
• Product: MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.
• Code Information: Model #781230. All lots
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Road; Cleveland OH 44143-2131
• For Additional Information Contact: Holly W. Lee; 440-483-7000
• Manufacturer Reason for Recall: Polymeric RF connector block on the tabletop overheated and eventually ignited during scanning due to combination of arcing of electrical components associated with the RF trap assembly located below the connector and flame rating of the connector block material.
• FDA Determined Cause: Other
• Action: An "Urgent-Field Safety Notice" dated December 4, 2009 was issued via certified mail to customers. The notification letter described the affected product, problem, hazard involved and action to be taken by customer. The customer will ensure to maintain frequent contact with patients during scanning and that the patient comfort kit is installed for all patient studies. The Customer will be visited by a Philips Service Representative to inspect their MRI System and install the newly remanufactured RF Connector Block. Additionally, step-by-step trap/cable installation instructions including pictures are being drafted to ensure correct installation of cabling. If you need any further information or support concerning this issue, please contact your local Philips representative or 1-800-722-9377.
• Quantity in Commerce: 290 units
• Distribution: Worldwide distribution- United states: (AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, LA, MA, MD, ME, MN, MO, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA & WI), ARGENTINA, BRAZIL, CANADA, CHINA, CYPRUS, FRANCE, GERMANY, GREECE, ITALY, JAPAN, KOREA, NEW ZEALAND, PAKISTAN, POLAND, RUSSIA, SWITZERLAND, TAIWAN & 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 = LNH