Natus Neurology recalls specific Nicolet Ambulatory EEG devices that may allow importing an exam not started. Affected units have unique serial numbers. No remedy stated in recall notice.
Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
Natus Neurology is recalling certain Nicolet Ambulatory EEG devices that could potentially import an exam for a patient who hasn't started the test. This issue doesn't pose a safety risk but may cause confusion in medical records.
The device may import an EEG exam record for a patient before the actual test begins. This could lead to inaccurate medical documentation if the exam wasn't properly initiated. The issue doesn't involve physical harm but affects data integrity.
Healthcare providers using the Nicolet Ambulatory EEG devices are likely affected. Patients receiving these devices for EEG monitoring may be at risk of incorrect medical records if the exam wasn't properly started.
Check for serial numbers listed in the recall: MBR120693, MBR100549, and other specific numbers provided in the notice. The device is manufactured by Natus Neurology Inc.
Look for the serial number on your Nicolet Ambulatory EEG device to see if it matches the list of affected numbers provided in the recall.
No, the recall doesn't indicate a safety hazard. The issue is about potential incorrect medical documentation if the exam wasn't started.
Check your device's serial number against the list provided in the recall notice. If it matches, you may want to contact Natus Neurology for further guidance.
The recall lists specific serial numbers starting with MBR or LBR. Check your device's serial number to see if it appears in the provided list.
We’ve drafted a message you can send Natus Neurology to request your refund or repair — edit it as you like.
Subject: Recall Z-2568-2018 — Natus Neurology Natus Neurology Hello, I own a Natus Neurology that is covered by recall Z-2568-2018 from Natus Neurology. 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.