Device recall

Z-0654-2009: CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.

FDA device recall · Class II · iCAD, Inc.

Key facts

Recall number (Z-number) Z-0654-2009
Recall event 50503
Product CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
Product code LNH
Recalling firm iCAD, Inc.
Recall class Class II
Status Terminated
Termination date Jan 28, 2016
FEI number 3026970882

At a glance

  • None 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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