Date Initiated by Firm |
March 30, 2007 |
Date Posted |
April 26, 2007 |
Recall Status1 |
Terminated 3 on August 07, 2007 |
Recall Number |
Z-0769-2007 |
Recall Event ID |
37760 |
510(K)Number |
K041112
|
Product Classification |
magnetic resonance imaging system with OR table - Product Code LNH
|
Product |
Magnetom Espree System with OR Table |
Code Information |
Model number 10092082, serial number 1002, 1003, and 1004. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
|
For Additional Information Contact |
Roland Richter 610-448-1777
|
Manufacturer Reason for Recall |
If table top is not seated properly it can lock up/stick.
|
FDA Determined Cause 2 |
Other |
Action |
The recalling firm issued a Safety Advisory Letter to their customers on March 30, 2007, informing them of the problem and steps to take to avoid the problem. |
Quantity in Commerce |
3 units |
Distribution |
The product was shipped to medical facilities in NY and TX. |
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.
|
510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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