Class 2 Device Recall Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T

• Date Initiated by Firm: August 07, 2013
• Date Posted: October 21, 2013
• Recall Status: Terminated on March 26, 2014
• Recall Number: Z-0033-2014
• Recall Event ID: 66312
• 510(K)Number: K003853 K013858 K964626 K971884
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
• Code Information: M/N: 781220, 781230, 781301, 78129 and 78127. Codes: AM128, 1510, 1518, BA318, AM120, ZA178, ZA196, ZA107, ZA133, ZA172, ZA158, BA149 and ZA208.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Dominic Siewko; 800-722-9377
• Manufacturer Reason for Recall: There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.
• FDA Determined Cause: Device Design
• Action: Philips Healthcare sent an Urgent Medical Device Correction letter via certified mail on August 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information with all of their staff who need to be aware of the contents of this communication. Philips Healthcare will perform any necessary corrective actions prior to the customer's next cryogen refill. Customers with questions were instructed to contact their Philips field service representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.
• Quantity in Commerce: Total 511 (Asset 0.5T,: 35 units Apollo 0.5T: 15 units, Infinion 1.5T: 116 units, Eclipse/Polaris 1.5T: 290 units, Panorama 0.6T: 55 units)
• Distribution: Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.
• 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