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 heart rate and blood flow sounds.
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. The hazard involves a diagnostic device potentially failing to provide clear audio feedback, which poses a risk of harm if clinical decisions are made based on masked data, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Natus Neurology Inc is recalling 2,335 units of the Nicolet Elite 3 MHz OB Probe (Model X1L001, Catalog Code N300). The recall also covers some Elite 2 Obstetric probes and 5 MHz Vascular Probes. These 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 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 markets.
Healthcare facilities and users should stop using the affected probes and contact Natus Neurology Inc for instructions on how to proceed. The specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- 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.
- Manufacturer
- Natus Neurology Inc
- 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 CAR0600.
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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