Optima MR450w 1.5T nuclear magnetic resonance imaging system
Reported: October 27, 2021 Initiated: August 26, 2021 #Z-0140-2022
Product Description
Optima MR450w 1.5T 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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 13 devices
- 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
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Optima MR450w 1.5T nuclear magnetic resonance imaging system. Recalled by GE Healthcare, LLC. Units affected: 13 devices.
Why was this product recalled? ▼
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0140-2022.
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