FDA recall Z-2587-2018

Product

CT Goldseal BrightSpeed 16 PWR TIO 2 YR

Reason for recall

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

Distribution

Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.

Key facts

Status

Terminated

Initiation date

2018-05-24

Report date

2018-08-08

Termination date

2019-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2018