Reported Jul 19, 2017 · Terminated

Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early…

Natus Neurology Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Natus Neurology Inc · 3150 Pleasant View Rd · Middleton, WI · 53562-4800

Is this the product you have?

    • Nicolet¿ Elite¿ 3 MHz OB Probe
    • Model #: X1L001
  • Catalog CodeN300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc
Lot codes and dates
  • Serial numbers

    1,706 of 1,706 codes

    • CAQ0100
    • CAQ0101
    • CAQ0102
    • CAQ0103
    • CAQ0104
    • CAQ0105
    • CAQ0106
    • CAQ0107
    • CAQ0108
    • CAQ0109
    • CAQ0110
    • CAQ0111
    • CAQ0112
    • CAQ0113
    • CAQ0114
    • CAQ0115
    • CAQ0116
    • CAQ0117
    • CAQ0118
    • CAQ0119
    • CAQ0120
    • CAQ0121
    • CAQ0122
    • CAQ0123
    • CAQ0124
    • CAQ0125
    • CAQ0126
    • CAQ0127
    • CAQ0128
    • CAQ0129
    • CAQ0130
    • CAQ0131
    • CAQ0132
    • CAQ0133
    • CAQ0134
    • CAQ0135
    • CAQ0136
    • CAQ0137
    • CAQ0138
    • CAQ0139
    • CAQ0140
    • CAQ0141
    • CAQ0142
    • CAQ0143
    • CAQ0144
    • CAQ0145
    • CAQ0146
    • CAQ0147
    • CAQ0148
    • CAQ0149
    • CAQ0150
    • CAQ0151
    • CAQ0152
    • CAQ0153
    • CAQ0154
    • CAQ0155
    • CAQ0156
    • CAQ0157
    • CAQ0158
    • CAQ0159
    CAR0580, and CAR0600
Amount recalled
2,335 units total

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 22, 2020 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.