Z-0141-2022 Class II
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- August 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 devices
Product Description
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 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
Code Information
Software version HD29.1; and HD16.2 (China only)