Device recall

Z-1061-2015: Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

FDA device recall · Class I · Alltech Medical Systems America Inc

Key facts

Recall number (Z-number) Z-1061-2015
Recall event 70238
Product Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Product code LNH
Recalling firm Alltech Medical Systems America Inc
Recall class Class I
Status Terminated
Termination date Sep 15, 2015
510(k) numbers K113511
FEI number 3007138967

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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