Recall Z-0134-2022 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
SIGNA Pioneer nuclear magnetic resonance imaging system
| Date | Oct 16, 2021 (initiated Aug 26, 2021) |
| Status | Terminated |
| Reason | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| Root cause | Software design |
| Action | GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator. |
| Quantity | 5 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 |
| FDA record | Open on fda.gov |