Discovery MR750w 3.0T nuclear magnetic resonance imaging system
- Company
- Ge Healthcare, Llc
- Recall Initiated
- August 26, 2021
- Posted
- October 16, 2021
- Recall Number
- Z-0135-2022
- Quantity
- 13 devices
- Firm Location
- Waukesha, WI
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
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 / Code Info
Software version DV29.1
Root Cause
Software design
Action Taken
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.