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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Mobilett XP Digital Mobile Xray System

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  Class 2 Device Recall Siemens Mobilett XP Digital Mobile Xray System see related information
Date Initiated by Firm May 09, 2014
Date Posted July 02, 2014
Recall Status1 Terminated 3 on December 15, 2014
Recall Number Z-1985-2014
Recall Event ID 68382
510(K)Number K033238  
Product Classification System, x-ray, mobile - Product Code IZL
Product Siemens Mobilett XP Digital Mobile X-ray System

Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.
Code Information model no. 1818447, with serial nos.: 3284 3449 1026 1025 1010 1041 1054 2002 2058 2022 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.
FDA Determined
Cause 2		 Component design/selection
Action Siemens sent a Safety Advisory Notice letter dated May 9, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that a Siemens service technician would be visiting their site to identify and service affected devices.
Quantity in Commerce 10
Distribution US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.
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.
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