Recall Z-0140-2022 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
Optima MR450w 1.5T 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142085 | DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T Ge Medical Systems, LLC, Sep 26, 2014 |
| K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T Ge Medical Systems, LLC, Jun 9, 2016 |
| K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artis Ge Medical Systems, LLC, Mar 17, 2017 |