AMX Navigate Mobile X-Ray System
This recall has been terminated (originally issued September 29, 2021).
- Company
- Ge Healthcare, Llc
- Recall Initiated
- June 24, 2021
- Posted
- September 29, 2021
- Terminated
- June 14, 2023
- Recall Number
- Z-2590-2021
- Quantity
- 3 units
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
Distribution
Domestic Distribution Only
Lot / Code Info
AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK
Root Cause
Process control
Action Taken
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.