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Class 2 Device Recall Mobilett XP Hybrid/Digital/CR |
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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
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Product Classification |
System, x-ray, mobile - Product Code IZL
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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
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For Additional Information Contact |
Meredith Adams 610-448-3237
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Manufacturer Reason for Recall |
battery fuse
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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
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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.
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510(K) Database |
510(K)s with Product Code = IZL and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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