Class 2 Device Recall Axiom Artis dMP

• Date Initiated by Firm: October 26, 2009
• Date Posted: December 03, 2009
• Recall Status: Terminated on January 26, 2010
• Recall Number: Z-0484-2010
• Recall Event ID: 53844
• 510(K)Number: K021021
• Product Classification: Angiographic x-ray system - Product Code IZI
• Product: Axiom Artis dMP, Model number 7555365 angiographic x-ray systems
• Code Information: Serial numbers: 57004, 57008, 57009, 57012, 57016, 57024, 57041, 57045, 57054, 57072, 57073, 57076, 57077, 57089, 57098, 57105, 57111, 57116, 57117, 57124, 57144, 57155, 57156, 57171, 57183, 57187, 57188, 57189, 57193, 57198, 57201, and 57204.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Meredith Adams; 610-219-6300
• Manufacturer Reason for Recall: c-arm may tilt
• FDA Determined Cause: Other
• Action: The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.
• Quantity in Commerce: 32 unit
• Distribution: Nationwide
• 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 = IZI