GE Healthcare, LLC SIGNA Voyager nuclear magnetic resonance imaging system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SIGNA Voyager nuclear magnetic resonance imaging system
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Software version VX29.1, and PX26.4 (China only)
Products Sold
Software version VX29.1; and PX26.4 (China only)
GE Healthcare, LLC is recalling SIGNA Voyager nuclear magnetic resonance imaging system due to Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026