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

Recall Z-2342-2012 — Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1NIM-Response 3.0 Patient InterfaceMedtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USARx OnlyLot***SN

U.S. FDA — Device Enforcement · United States · 2010-09-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2342-2012
Date of alert: 2010-09-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Xomed, Inc.
Product category: device
Product type: Devices

Reported risk: In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu

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.

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.

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