# FDA recall Z-1630-2020

> **Natus Neurology DBA Excel Tech., Ltd. (XLTEK)** · Class II · device recall initiated 2020-03-05.

## Product

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.

## Distribution

Worldwide distribution.  US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom

## Key facts

- **Recall number:** Z-1630-2020
- **Recalling firm:** Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-05
- **Report date:** 2020-04-08
- **Termination date:** 2021-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oakville, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1630-2020

## Citation

> AI Analytics. FDA recall Z-1630-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1630-2020. Source: US FDA. Licensed CC0.

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