Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0170-2020 — The ICS CHARTR EP 200

U.S. FDA — Device Enforcement · Denmark · 2019-05-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0170-2020
Date of alert
2019-05-28
Country / jurisdiction
Denmark
Risk level
Class II
Risk type
recall
Brand
GN Otometrics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05713315006449
Reported risk: There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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