Recall Z-0170-2020— GN Otometrics

Name: FDA recall Z-0170-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-28

Class II · Terminated

Class II FDA medical device recall by GN Otometrics, initiated 2019-05-28, terminated 2021-04-09. It names one FDA 510(k) clearance: K083399. Product: The ICS CHARTR EP 200. Reason: There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock..

Recalling firm: GN Otometrics
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Terminated: 2021-04-09
Firm location: Taastrup, Denmark

510(k) clearances named in this recall

1 on FDA's record

K083399 — ICS CHARTR EP 200Gn Otometrics A/S·cleared 2009-02-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The ICS CHARTR EP 200

Reason for recall

There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.

Data sourced from openFDA. This site is unofficial and independent of the FDA.