Skip to content
Recall Observatory FDA recall evidence

Device product

Optima MR450w 1.5T nuclear magnetic resonance imaging system

Z-0140-2022

August 26, 2021

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 88665
Status
Terminated
Classification
Class II
Quantity
13 devices
Official record key
device-enforcement:Z-0140-2022

Official wording

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

Code information: Software version DV29.1

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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