Alltech Medical Systems America Inc recalls Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
- Recall date
- January 9, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1061-2015
- FDA classification
- Class I
- Brand / firm
- Alltech Medical Systems America Inc
- Sold / distributed
- US Distribution in the state of Maryland.
Why it was recalled
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
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