FDAJune 9, 2017device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
natus neurologynatus
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANatus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph2025-06-18
- FDABrand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No2025-05-07
- FDATENSIVE Conductive Adhesive Gel, REF 016-4016002024-02-07
- FDAnatus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 0242522024-02-07
- FDAEDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only2023-11-28
- FDAExternal Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only2023-11-28
- FDAThe Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of th...2022-11-18
- FDAIPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software2021-12-02
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