FDAFDA · Food and drugs·Recall number Z-0134-2022
SIGNA Pioneer nuclear magnetic resonance imaging system
Published October 27, 2021 · Recall initiated: August 26, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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
- Lot
- Software version PX29.1; and PX25.4 (T), PX28.3 (China only)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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