FDA recall Z-0607-2019

GE Healthcare, LLC · Class II · device

Product

Discovery NM/CT 670 ES, model 5376204-70-57

Reason for recall

When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.

Distribution

CA, DC, OH, UT, WI, Canada

Key facts

Status
Completed
Initiation date
2018-05-24
Report date
2018-12-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0607-2019