Natus Neurology Recalls Elite Obstetric Probes Due to Excessive Background Noise
Natus Neurology is recalling 2,335 Elite Obstetric probes because excessive background noise may mask fetal heart rate and blood flow monitoring.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect (excessive noise) poses a risk of harm by masking critical monitoring data, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Natus Neurology Inc is recalling 2,335 units of the Nicolet Elite 2 MHz OB Water Proof Probe, Model X1L008, Catalog Code NW20. The recall also includes some Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes. The affected devices are intended for non-invasive support, including early detection of fetal life and monitoring blood flow before and after surgery.
The recall was initiated because some of these probes may exhibit excessive background noise. This noise may mask the user's ability to clearly hear heart rate and/or blood flow. The affected serial numbers range from CHR0140 to CHR0161.
The products were distributed worldwide, including in the United States and various international countries. Users should contact Natus Neurology Inc for further instructions on how to address the issue.
The recalled product
- Product
- Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
- Manufacturer
- Natus Neurology Inc
- Category
- Medical Device — Obstetric Probe
- Affected units
- 2,335
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- and CHR0161.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Natus Neurology Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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