FDA recall Z-0430-2021

Product

Niobe ES System, Models 001-006000-1 and 001-006100-1

Reason for recall

There is a potential for fire in the inside computer cabinet.

Distribution

US and OUS distribution: US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA OUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan

Key facts

Status

Terminated

Initiation date

2020-09-21

Report date

2020-11-18

Termination date

2023-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0430-2021