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Lower risk Medical device recall · FDA · Published March 5, 2020

Natus Olympic Brainz Monitor Recall: Unverified System Functionality

Natus recalls Olympic Brainz Monitor (REF OBM00002) due to unverified electroencephalograph functionality. Affected units may not work correctly for newborn care.

🇺🇸 FDA recall #Z-1630-2020Medical deviceNatus ›
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Recalling firmNatus Neurology DBA Excel Tech., Ltd. (XLTEK)2568 Bristol Cir · Oakville, Canada
✎ GovInfoNow plain-language explainer

Natus is recalling newborn brain monitors with serial numbers starting OBM00002G2119 to OBM00002G2168 because they were not tested for proper function before release. This could mean the monitor might not work correctly for critical newborn health monitoring. Read more at govinfonow.com/recall/65713-natus-olympic-brainz-monitor-recall-unverified-system-functionality.

Source Summary by GovInfoNow · govinfonow.com/recall/65713-natus-olympic-brainz-monitor-recall-unverified-system-functionality · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1630-2020

Cite this page

“Natus Olympic Brainz Monitor Recall: Unverified System Functionality.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65713-natus-olympic-brainz-monitor-recall-unverified-system-functionality. Based on FDA recall #Z-1630-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1630-2020%22&limit=1).

The FDA announced on March 5, 2020, that Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling its natus newborn care Olympic Brainz Monitor, REF OBM00002, because the manufacturer cannot attest to system functionality. The recall affects 40 units distributed worldwide.

How to tell if you have it

  • Brand: Natus
  • Product: natus newborn care Olympic Brainz Monitor
  • REF: OBM00002
  • Serial Numbers: OBM00002G2119 through OBM00002G2168

The hazard

The OBM system functional test, including impedance and noise checks, was not carried out on the affected items prior to release. Consequently, the manufacturer cannot attest to the system functionality of these units.

Context

GovInfoNow's records show Natus Neurology DBA Excel Tech., Ltd. (XLTEK) has issued five other recalls since May 15, 2018. Recent similar product recalls include a Philips Avalon Fetal Monitor recall on May 26, 2026, and two Philips IntelliVue monitor recalls on October 31, 2025.

How to tell if you have this one

Check for serial numbers starting with OBM00002G2119 to OBM00002G2168 on the monitor's label. The product is a newborn care electroencephalograph sold by Natus Neurology.

  • Brand
    Natus
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Look for serial numbers starting with OBM00002G2119 to OBM00002G2168 on the monitor's label.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Mar 5, 202012. FDA classified it Class II: Apr 1, 202023. Published in FDA’s Enforcement Report: Apr 8, 202034. FDA terminated the recall: Aug 9, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1630-2020 (March 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1630-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA