Z-1061-2015Class I

Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body

Name: Z-1061-2015 Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body
Creator: Alltech Medical Systems America Inc
Published: 2015-01-09
License: https://open.fda.gov/license/

Alltech Medical Systems America, Inc. / initiated 2015-01-09 / Terminated / root cause: manufacturing process

FDA source

Alltech Medical Systems America Inc began a recall of Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body on 2015-01-09. FDA classified it as Class I and gives the reason as "The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1061-2015
Classification: Class I
Status: Terminated
Initiated: 2015-01-09
Posted: 2015-02-18
Terminated: 2015-09-15
Recalling firm: Alltech Medical Systems America, Inc.
Product: Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Serial numbers: D-ESP-1001 and D-ESP-1003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1061-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1061-2015	Class I	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-18

Product code LNH

K113511Class IIEchostar Spica 1.5T Mr SystemAlltech Medical Systems America, Inc. / cleared 2012-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)