GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-0140-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Optima MR450w 1.5T nuclear magnetic resonance imaging system

Product Classification:

Class II

Date Initiated: August 26, 2021

Date Posted: October 27, 2021

Recall Number: Z-0140-2022

Event ID: 88665

Reason for Recall:

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

Status: Ongoing

Product Quantity: 13 devices

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

Voluntary or Mandated:

Voluntary: Firm initiated