natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Reported: April 8, 2020 Initiated: March 5, 2020 #Z-1630-2020
Product Description
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Reason for Recall
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 of the affected items.
Details
- Recalling Firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Units Affected
- 40 units
- Distribution
- Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom
- Location
- Oakville, N/A
Frequently Asked Questions
What product was recalled? ▼
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph. Recalled by Natus Neurology DBA Excel Tech., Ltd. (XLTEK). Units affected: 40 units.
Why was this product recalled? ▼
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 of the affected items.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2020. Severity: Moderate. Recall number: Z-1630-2020.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11