fda
8 records
FDA Recall: Natus Neurology DBA Excel Tech., Ltd. (XLTEK) — Class II
20250618
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location i | Product: Brand Name: OBM00002 OBM DAB (Digital ...
View Source
FDA Device Recall: Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard elec
2025-07-30
Class II — Natus received two complaints of left side labeling show impedance for right side.
View Source
FDA Device Recall: Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 O
2025-06-18
Class II — Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
View Source
FDA Device Recall: IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neurowo
2022-03-02
Class II — Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner styl...
View Source
FDA Device Recall: natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
2020-04-08
Class II — The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality o...
View Source
FDA Recall: Natus Neurology DBA Excel Tech., Ltd. (XLTEK) — Class II
20180808
Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plast | Product: XLTEK EMU40EX EEG Headbox
View Source
FDA Device Recall: XLTEK EMU40EX EEG Headbox
2018-08-08
Class II — Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting.
View Source
FDA Device Recall: Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.
2016-01-13
Class II — During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.
View Source
Be informed when major changes happen on C.F.A.I. — new data sources, platform updates, critical enforcement alerts
No spam. Only major updates. Unsubscribe anytime.