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U.S. Department of Health and Human Services

Class 1 Device Recall Echostar Spica

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 Class 1 Device Recall Echostar Spicasee related information
Date Initiated by FirmJanuary 09, 2015
Date PostedFebruary 18, 2015
Recall Status1 Terminated 3 on September 15, 2015
Recall NumberZ-1061-2015
Recall Event ID 70238
510(K)NumberK113511 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductEchostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Code Information Serial numbers: D-ESP-1001 and D-ESP-1003
FEI Number 3007138967
Recalling Firm/
Manufacturer		 Alltech Medical Systems America Inc
28900 Fountain Pkwy
Solon OH 44139-4383
For Additional Information ContactWilliam 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
ActionAltech 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 Commerce2 units
DistributionUS Distribution in the state of Maryland.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
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