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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 Recall
Siemens Mobilett XP Digital Mobile Xray System
see related information
Date Posted July 02, 2014
Recall Status1 Open
Recall Number Z-1985-2014
Recall Event ID 68382
Premarket Notification
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, Pennsylvania 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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