FDA recall Z-2349-2024

Product

Cascade IOMAX Cortical Module, REF: 190296-200

Reason for recall

Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

Distribution

US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom

Key facts

Status

Ongoing

Initiation date

2024-05-17

Report date

2024-07-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kennewick, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2349-2024