Natus Neurology Recalls Elite 5 MHz Vascular Probes Due to Noise Issues
Natus Neurology is recalling 2,335 Elite 5 MHz Vascular Probes because excessive background noise may mask heart rate and blood flow signals.
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 is classified as FDA Class II, and the hazard involves a risk of harm (masking vital signs) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Natus Neurology Inc is recalling 2,335 units of the Nicolet Elite 5 MHz Vascular Probe (Model #: X1L004, Catalog Code: N500). The device is 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 the affected 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 units were distributed worldwide, including in the United States and various international countries. Users should check their serial numbers against the list provided by the manufacturer or the FDA to determine if their device is affected.
The recalled product
- Product
- Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. 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 — Diagnostics
- 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 CBR0315.
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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