Class 2 Device Recall Mobilett XP

• Date Initiated by Firm: October 04, 2010
• Date Posted: November 01, 2010
• Recall Status: Terminated on September 29, 2012
• Recall Number: Z-0171-2011
• Recall Event ID: 56921
• 510(K)Number: K033238
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: Mobilett XP and Mobilett XP Hybrid, Mobile radiology device; System, x-ray, mobile
• Code Information: Model numbers 1818363 and 1818454
• 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: Units not equipped with protective plastic cover over electronics.
• FDA Determined Cause: Device Design
• Action: Siemens Medical Solutions USA, Inc issued a mandatory field update. The letter identified the product, the problem and the action to be taken by the customer. All systems that were not yet equipped with protective cover over the D972 board would be upgraded. For questions regarding this recall call (610) 448-3237.
• Quantity in Commerce: 177 units
• Distribution: Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA, WA, WI, WY AND PUERTO RICO.
• 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 and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.