Reported Feb 25, 2015 · Terminated

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

Alltech Medical Systems America Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alltech Medical Systems America Inc · 28900 Fountain Pkwy · Solon, OH · 44139-4383

Is this the product you have?

  • Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Lot codes and dates
  • Serial numbersD-ESP-1001 and D-ESP-1003
Amount recalled
2 units

Where it was sold

Why it was recalled

Stop using this product now

The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 15, 2015 · Data as of Sep 19, 5:32 PM UTC

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