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U.S. Department of Health and Human Services

Class 2 Device Recall Mobilett XP

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 Class 2 Recall
Mobilett XP
see related information
Date Posted November 01, 2010
Recall Status1 Terminated on September 29, 2012
Recall Number Z-0171-2011
Recall Event ID 56921
Premarket Notification
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, Pennsylvania 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 2
DESIGN: 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 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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