Alpha Omega Engineering recalls Neuro Omega System devices with specific serial numbers for potential tissue harm if cables are improperly connected. Affected units include 113, 115, 116, and other serial numbers listed in the recall notice.
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Alpha Omega Engineering is recalling Neuro Omega System devices that use HaGuide software for neurological and neurosurgical applications. The recall is due to a risk of tissue harm if cables are improperly connected, which could lead to high charge density in the device.
Improper cable connections can cause high charge density in the device, which may lead to tissue harm. This risk occurs when the system is used for monitoring, recording, and stimulating nerves and brain tissue without correct cable connections.
Medical professionals using the Neuro Omega System for neurological or neurosurgical procedures are most at risk. Patients receiving treatment with this device may also be affected if the system is improperly connected.
Check the serial numbers listed: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04, 161/04, 167, 175/06, 176/06, 177/06, 180/06, 182/06, 185/06, 188/06, and 189.
Identify if your device has a serial number from the list: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04, 161/04, 167, 175/06, 176/06, 177/06, 180/06, 182/06, 185/06, 188/06, or 189.
The Neuro Omega System is used for neurological and neurosurgical procedures, including monitoring, recording, and displaying bioelectric signals, and stimulating nerves and brain tissue.
Check the serial number on your device against the list: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04, 161/04, 167, 175/06, 176/06, 177/06, 180/06, 182/06, 185/06, 188/06, and 189.
The recall does not specify a remedy, so contact Alpha Omega Engineering directly for guidance on next steps.
We’ve drafted a message you can send Alpha Omega Engineering to request your refund or repair — edit it as you like.
Subject: Recall Z-1216-2019 — Alpha Omega Engineering Alpha Omega Engineering Hello, I own a Alpha Omega Engineering that is covered by recall Z-1216-2019 from Alpha Omega Engineering. 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.
