Device product
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Z-0141-2022
Product summary
- Event
- Event 88665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 devices
- Official record key
device-enforcement:Z-0141-2022
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 HD29.1; and HD16.2 (China only)
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
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.