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U.S. Department of Health and Human Services

Class 2 Device Recall Mobilett XP Hybrid/Digital/CR

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  Class 2 Device Recall Mobilett XP Hybrid/Digital/CR see related information
Date Initiated by Firm October 04, 2010
Date Posted December 17, 2010
Recall Status1 Terminated 3 on September 29, 2012
Recall Number Z-0718-2011
Recall Event ID 57312
510(K)Number K033238  
Product Classification System, x-ray, mobile - Product Code IZL
Product Mobilett XP Hybrid/Digital/CR

Intended use: mobile x-ray system
Code Information Model numbers 1818454, 1818447, and 1818959
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Meredith Adams
610-448-3237
Manufacturer Reason
for Recall		 battery fuse
FDA Determined
Cause 2		 Other
Action SIEMENS released a field update dated October 25, 2010, via SP011/10/S to the representatives. The update described issue and corrective action plan. The representatives are to visit each account to upgrade the systems with a new battery fuse and a new holder. If you have any questions regarding this report, please contact Quality Engineer by phone 610-448-3237 or email: meredith.adams@siemens.com and Director, Product complaints & Field Support by phone 610-448-4634 or email: josephine.mcbride@siemens.com.
Quantity in Commerce 170 units
Distribution Nationwide distribution: AZ, CA, DC, MD, PA, SC and VA.
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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