Class 2 Device Recall Siemens Mobilette Mira

• Date Initiated by Firm: October 10, 2012
• Date Posted: December 06, 2012
• Recall Status: Terminated on January 15, 2014
• Recall Number: Z-0480-2013
• Recall Event ID: 63495
• 510(K)Number: K111912
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: Siemens Mobilette Mira, intended use as Mobile x-ray system.
• Code Information: Model Number 10273100
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Anastasia Mason; 610-219-4834
• Manufacturer Reason for Recall: There is a risk of lost images during examination.
• FDA Determined Cause: Software design
• Action: The firm initiated their recall/correction of this product on September 9, 2012 by sending a Field Safety Notification letter with Update Instruction XP054/12/S to all consignees. The letter described the steps to be taken to avoid the potential risk and included a response form to be returned to the recalling firm.
• Quantity in Commerce: 21
• Distribution: Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, 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 = IZL