GE Healthcare, LLC AMX Navigate Mobile X-Ray System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMX Navigate Mobile X-Ray System
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK
Products Sold
AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK
GE Healthcare, LLC is recalling AMX Navigate Mobile X-Ray System due to An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
Recommended Action
Per FDA guidance
On June 24, 2021 the firm contacted the facilities that received the device via email. An AMX Navigate system was provided to 3 healthcare facilities for evaluation under an agreement with GE Healthcare. While at the healthcare facilities, these systems remained under the ownership of GE Healthcare. After one of the healthcare facilities alerted GE Healthcare to a potential issue with its system, GE Healthcare removed the system from the 3 healthcare facilities in order to perform a detailed engineering analysis as part of its root cause investigation. These 3 systems have not been returned to the healthcare facilities and remain in GE Healthcare s possession.
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