Device recall

Z-0170-2020: The ICS CHARTR EP 200

FDA device recall · Class II · GN Otometrics

Key facts

Recall number (Z-number) Z-0170-2020
Recall event 83380
Product The ICS CHARTR EP 200
Product code GWJ
Recalling firm GN Otometrics
Recall class Class II
Status Terminated
Termination date Apr 9, 2021
510(k) numbers K083399
FEI number 3002807554

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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