FDA recall Z-0141-2022

Product

1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Distribution

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

Key facts

Status

Terminated

Initiation date

2021-08-26

Report date

2021-10-27

Termination date

2026-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0141-2022