Class 3 Device Recall Infinion 1.5 T MRI Scanner.

• Date Initiated by Firm: April 17, 2003
• Date Posted: December 02, 2004
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-0272-05
• Recall Event ID: 30416
• 510(K)Number: K003853 K011296
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Intinion 1.5 T MRI Scanner.
• Code Information: Serial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Road; Cleveland OH 44143-2131
• For Additional Information Contact: Michael J. Hayes; 440-483-3521
• Manufacturer Reason for Recall: There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.
• FDA Determined Cause: Other
• Action: A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.
• Quantity in Commerce: 93 units.
• Distribution: Throughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico.
• 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