Date Initiated by Firm |
January 09, 2015 |
Date Posted |
February 18, 2015 |
Recall Status1 |
Terminated 3 on September 15, 2015 |
Recall Number |
Z-1061-2015 |
Recall Event ID |
70238 |
510(K)Number |
K113511
|
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
Product |
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. |
Code Information |
Serial numbers: D-ESP-1001 and D-ESP-1003 |
Recalling Firm/ Manufacturer |
Alltech Medical Systems America Inc 28900 Fountain Pkwy Solon OH 44139-4383
|
For Additional Information Contact |
William Joliat 440-424-2240
|
Manufacturer Reason for Recall |
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
|
FDA Determined Cause 2 |
Process control |
Action |
Altech Medical Systems America Inc., notified customers on January 9, 2015, of the problem via telephone. Customers were instructed to immediately cease using the product until the correction can be made. A follow-up letter was sent through the mail, which stated that a service engineer would make a site visit to ramp down the magnet until the issue can be corrected. Customers were asked to complete the attached Acknowledgement and Receipt Form and fax it to (440) 424-2255. For questions contact AMSA at 1-855-200-2672. |
Quantity in Commerce |
2 units |
Distribution |
US Distribution in the state of Maryland. |
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 = ALLTECH MEDICAL SYSTEMS AMERICA, INC.
|