Class 2 Device Recall Magnetom Avanto

• Date Initiated by Firm: August 12, 2005
• Date Posted: September 09, 2005
• Recall Status: Terminated on July 19, 2006
• Recall Number: Z-1528-05
• Recall Event ID: 33308
• 510(K)Number: K032428
• Product Classification: unknown device name - Product Code LNN
• Product: Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167
• Code Information: Serial numbers 25007 to 25557
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore
• FDA Determined Cause: Other
• Action: The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
• Quantity in Commerce: 209 units
• Distribution: The products were shipped to medical facilities and MRI facilities nationwide.

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 = LNN