Class 2 Device Recall Mobilett Mira Mobile Xray

• Date Initiated by Firm: May 02, 2013
• Date Posted: August 05, 2013
• Recall Status: Terminated on February 24, 2015
• Recall Number: Z-1875-2013
• Recall Event ID: 65605
• 510(K)Number: K111912
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: Mobiletta Mira 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: Siemens Customer Service; 888-826-9702
• Manufacturer Reason for Recall: Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This
• FDA Determined Cause: Device Design
• Action: Siemens sent a Field Safety Notice dated May 2. 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to : 1) Never step or sit on the unit or otherwise put substantial weight on it. 2) Avoid moving the unit over high thresholds for doors or elevators where possible, or do so carefully and slowly. 3) Make sure that no person had his/her extremities under the chassis, also when the unit is not moving. Update instructions were also released to alert customers of the potential risk and to provide a hardware change which is intended to improve corrosion resistance. An acknowledgement of receipt form was also sent out for the field safety notice and requested to be returned to Siemens. For further questions please call (888) 826-9702.
• Quantity in Commerce: 39
• Distribution: US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.
• 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