Natus Neurology Recalls Elite 2 MHz OB Probes Due to Excessive Noise
Natus Neurology is recalling 2,335 Elite 2 MHz OB probes because excessive background noise may mask the user's ability to hear heart rate or blood flow.
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 product (medical device) where the defect could mask critical physiological signals, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Natus Neurology Inc is recalling 2,335 units of the Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor (Model X1L007, Catalog Code N200). 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 the Elite 2 and 3 Obstetric probes and 5 MHz Vascular 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. Specific serial numbers for the recalled units range from CER0179 to CER0321. Users should contact Natus Neurology Inc for further instructions regarding the recall.
The recalled product
- Product
- Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. 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 CER0321.
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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