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

Recall Z-2728-2017 — Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

U.S. FDA — Device Enforcement · United States · 2017-06-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2728-2017
Date of alert: 2017-06-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Natus Neurology Inc
Product category: device
Product type: Devices

Reported risk: Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

Recall Z-2728-2017 — Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

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