Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
FDA device recall Z-1061-2015 · posted 2015-02-18 · Terminated
Recall details
- Recalling firm
- Alltech Medical Systems America Inc
- Reason for recall
- The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
- Action taken
- 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
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 2 units
- Distribution
- US Distribution in the state of Maryland.
- Date initiated
- 2015-01-09
- Date posted
- 2015-02-18
- Date terminated
- 2015-09-15
- Location
- Solon, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECHOSTAR SPICA 1.5T MR SYSTEM (K113511) | Alltech Medical Systems America, Inc. | 2012-05-02 |