Class 3 Device Recall Magnetom Trio

• Date Initiated by Firm: December 18, 2003
• Date Posted: February 10, 2004
• Recall Status: Terminated on November 09, 2004
• Recall Number: Z-0521-04
• Recall Event ID: 28046
• 510(K)Number: K013586
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Magnetom Trio System. Nuclear Magnetic Resonance Imaging Diagnostic Device
• Code Information: Model #7387074 - Serial #''s: 20501 through 20508, 20510 through 20524, and 20550 through 20570. Model #7106441 - Serial # 20500
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter; 610-448-17777
• Manufacturer Reason for Recall: tissue roll can become magnetic
• FDA Determined Cause: Other
• Action: The recalling firm has issued Updated Instructions to replace the stainless steel tissue roll holder. The recalling firm''s representatives are visiting each account to replace the tissue roll holder.
• Quantity in Commerce: 16 units
• Distribution: The product was shipped to medical facilities in CA, CT, DC, FL, GA, IL, IN, KS, KY, MA, MD, MN, NC, NY, OH, OR, PA, TX, and UT.
• 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 and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.