Date Initiated by Firm |
August 12, 2005 |
Date Posted |
September 09, 2005 |
Recall Status1 |
Terminated 3 on July 19, 2006 |
Recall Number |
Z-1528-05 |
Recall Event ID |
33308 |
510(K)Number |
K032428
|
Product Classification |
unknown device name - Product Code LNN
|
Product |
Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167 |
Code Information |
Serial numbers 25007 to 25557 |
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 |
there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore
|
FDA Determined Cause 2 |
Other |
Action |
The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence. |
Quantity in Commerce |
209 units |
Distribution |
The products were shipped to medical facilities and MRI facilities nationwide. |
|
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 = LNN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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