Drug recall

Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized…

FDA recall event 84070 · Class II · Neocis Inc.

Key facts

Event ID 84070
Recall numbers Z-0511-2020
Recalling firm Neocis Inc.
Product type Devices
Products Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and…
Classification Class II
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Initiation date Oct 4, 2019
Report date Nov 27, 2019
Termination date Oct 5, 2020
City Miami
State FL
Country United States
FEI number 3012787974

At a glance

  • 1–9 Products in this recall
  • 1–9 FDA inspections of this firm (FEI)

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

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