Class 2 Device Recall Axiom Aristos TX

• Date Initiated by Firm: June 10, 2005
• Date Posted: July 13, 2005
• Recall Status: Terminated on August 30, 2006
• Recall Number: Z-0988-05
• Recall Event ID: 32516
• 510(K)Number: K013826
• Product Classification: System, X-Ray, Stationary - Product Code KPR
• Product: Axiom Aristos TX. Model number 58 94 873; Radiology system
• Code Information: Serial numbers 1001 through 1077
• 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: potential issue (system may lock up) when repeating patient registrations
• FDA Determined Cause: Other
• Action: The recalling firm issed a Customer Advisory Letter via certified mail to their cutomers informing them of the problem and information for the workaround to prevent problems for occurring until the software is upgraded.
• Quantity in Commerce: 72 units
• Distribution: Nationwide. The products were shipped to hospitals in AZ, CA, CO, FL, GA, IL, IN, KS, KY, ME, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA, WA, and WI.
• 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 = KPR and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.