FDA Medical Device Recalls (openFDA)
Alltech Medical Systems America Inc: Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
- Recall number
- Z-1061-2015
- Recalling firm
- Alltech Medical Systems America Inc
- Product
- Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
- Status
- Terminated
- Initiated
- 2015-01-09
- Posted
- 2015-02-18
- Terminated
- 2015-09-15
- Reason
- The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
- 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
- 2 units
- Distribution
- US Distribution in the state of Maryland.
- Lot, serial or model codes
- Serial numbers: D-ESP-1001 and D-ESP-1003
- 510(k) numbers
- ["K113511"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3007138967
- Firm city
- Solon
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28