Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
FDA Recall Z-1061-2015 · Posted 2015-02-18
Recalling FirmAlltech Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2015-01-09
Date Terminated2015-09-15
Product Quantity2 units
Reason for Recall
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Distribution in the state of Maryland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.