Z-1216-2019 Class I Terminated
FDA device recall Z-1216-2019 was initiated by Alpha Omega Engineering on September 4, 2018 and is designated Class I. Reason for recall: If cables are improperly connected, current may reach high charge density, causing tissue harm. The recall status is terminated (terminated November 3, 2020). Affected quantity: 29.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- September 4, 2018
- Termination Date
- November 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29
Product Description
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
Reason for Recall
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Distribution Pattern
US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA
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.