Device product
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
Z-1216-2019
Product summary
- Event
- Event 82540
- Status
- Terminated
- Classification
- Class I
- Quantity
- 29
- Official record key
device-enforcement:Z-1216-2019
Official wording
Reason: If cables are improperly connected, current may reach high charge density, causing tissue harm.
Code information: Serial numbers: 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.
Distribution pattern: US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA
Derived failure modes
-
Unknown
If cables are improperly connected, current may reach high charge density, causing tissue harm.