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

Recall Z-2407-2019 — Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes

U.S. FDA — Device Enforcement · United States · 2019-06-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2407-2019
Date of alert
2019-06-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ad-Tech Medical Instrument Corporation
Product category
device
Product type
Devices
Reported risk: Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.