Alpha Omega Engineering Recalls Neuro Omega System Due to Design Flaw Which May Cause Significant Tissue Harm
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Neuro Omega System including the Drive Headstage unit
- Catalogue Number: (Neuro Omega) NOM-000000-00 + (Drive) 750-000020-00 + (EMG) 750-000010-00 (EEG) 750-000010-12.
- Manufacturing Dates: January 1, 2013 to January 9, 2018
- Distribution Dates: January 1, 2013 to January 9, 2018
- Devices Recalled in the U.S.: 29
- Date Initiated by Firm: March 28, 2019
The Neuro Omega system including the Drive Headstage unit, is used to assist neurosurgeons in identifying brain structures during functional neurosurgery and to aid in the placement of depth electrodes for seizure monitoring.
Reason for Recall
Alpha Omega Engineering is recalling the Neuro Omega System because a design flaw in the device may connect two separate electrode stimulation channels into one causing unwanted and higher than expected electrical stimulation. This high electrical stimulation may cause significant harm to a patient’s brain tissue.
Alpha Omega Engineering received one report of the electrode malfunction. No patient injuries or deaths related to this issue have been reported.
Who is affected?
- Neurosurgeons and assisting medical personnel who use the Neuro Omega System in the operating room.
- Patients receiving surgery performed on the nervous system, especially the brain and spinal cord (neurosurgery).
What to Do
On September 4, 2018, Alpha Omega Engineering notified and instructed consignees to stop or limit use of the device. An updated advisory notice was issued to consignees on March 4, 2019.
Customers should refer to the advisory notice for updated device labeling and more information on the circumstances in which device malfunction will occur and the risks when stimulation electrodes are incorrectly connected to the device.
Customers who have questions or need additional information or support regarding this recall should contact Alpha Omega Engineering Customer Service at 1-877-919-6288.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.