Recall Z-2728-2017— Natus Neurology Inc
Class II · Terminated
Class II FDA medical device recall by Natus Neurology Inc, initiated 2017-06-09, terminated 2020-07-22. It names one FDA 510(k) clearance: K982635. 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.. Reason: 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..
- Recalling firm
- Natus Neurology Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-09
- Terminated
- 2020-07-22
- Firm location
- Middleton, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.