Reported Jul 19, 2017 · Terminated

Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e.…

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¿ 5 MHz Vascular Probe
    • Model #: X1L004
  • Catalog CodeN500. 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

    524 of 524 codes

    • CBQ0302
    • CBQ0344
    • CBQ0385
    • CBQ0386
    • CBQ0387
    • CBQ0388
    • CBQ0389
    • CBQ0390
    • CBQ0391
    • CBQ0392
    • CBQ0393
    • CBQ0394
    • CBQ0395
    • CBQ0396
    • CBQ0397
    • CBQ0398
    • CBQ0399
    • CBQ0400
    • CBQ0401
    • CBQ0402
    • CBQ0403
    • CBQ0404
    • CBQ0410
    • CBQ0411
    • CBQ0412
    • CBQ0413
    • CBQ0414
    • CBQ0415
    • CBQ0416
    • CBQ0417
    • CBQ0418
    • CBQ0419
    • CBQ0420
    • CBQ0421
    • CBQ0422
    • CBQ0423
    • CBQ0424
    • CBQ0425
    • CBQ0426
    • CBQ0427
    • CBQ0428
    • CBQ0429
    • CBQ0430
    • CBQ0431
    • CBQ0432
    • CBQ0433
    • CBQ0434
    • CBQ0435
    • CBQ0436
    • CBQ0437
    • CBQ0438
    • CBQ0439
    • CBQ0440
    • CBQ0441
    • CBQ0442
    • CBQ0443
    • CBQ0444
    • CBQ0445
    • CBQ0446
    • CBQ0447
    CBR0314, and CBR0315
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, 6:07 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.