FDA recall Z-0127-2021

Product

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

Key facts

Status

Terminated

Initiation date

2020-09-08

Report date

2020-10-28

Termination date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2021