|
Class 3 Device Recall Magnetom Trio |
|
Date Initiated by Firm |
December 18, 2003 |
Date Posted |
February 10, 2004 |
Recall Status1 |
Terminated 3 on November 09, 2004 |
Recall Number |
Z-0521-04 |
Recall Event ID |
28046 |
510(K)Number |
K013586
|
Product Classification |
System, Nuclear Magnetic Resonance Imaging - Product Code LNH
|
Product |
Magnetom Trio System. Nuclear Magnetic Resonance Imaging Diagnostic Device |
Code Information |
Model #7387074 - Serial #''s: 20501 through 20508, 20510 through 20524, and 20550 through 20570. Model #7106441 - Serial # 20500 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
|
For Additional Information Contact |
Roland Richter 610-448-17777
|
Manufacturer Reason for Recall |
tissue roll can become magnetic
|
FDA Determined Cause 2 |
Other |
Action |
The recalling firm has issued Updated Instructions to replace the stainless steel tissue roll holder. The recalling firm''s representatives are visiting each account to replace the tissue roll holder. |
Quantity in Commerce |
16 units |
Distribution |
The product was shipped to medical facilities in CA, CT, DC, FL, GA, IL, IN, KS, KY, MA, MD, MN, NC, NY, OH, OR, PA, TX, and UT. |
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 = LNH and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
|
|
|
|