Natus recalls Olympic Brainz Monitor (REF OBM00002) due to unverified electroencephalograph functionality. Affected units may not work correctly for newborn care.
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.
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.
The monitor was not tested for proper electrical impedance and noise levels before being sold. This means it might not accurately track brain activity in newborns, potentially leading to missed health issues.
Newborn caregivers who own the Olympic Brainz Monitor with specific serial numbers are affected. Newborns using this monitor without verified functionality are at risk of inaccurate health readings.
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.
Look for serial numbers starting with OBM00002G2119 to OBM00002G2168 on the monitor's label.
The manufacturer couldn't verify the system functionality because the monitor wasn't tested for proper electrical impedance and noise levels before release.
Check the serial number. If it starts with OBM00002G2119 to OBM00002G2168, stop using it and contact Natus for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Natus to request your refund or repair — edit it as you like.
Subject: Recall Z-1630-2020 — Natus Natus Hello, I own a Natus that is covered by recall Z-1630-2020 from Natus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
