FDA recall Z-2590-2021
GE Healthcare, LLC · Class II · device
Product
AMX Navigate Mobile X-Ray System
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
Key facts
- Status
- Terminated
- Initiation date
- 2021-06-24
- Report date
- 2021-10-06
- Termination date
- 2023-06-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waukesha, WI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2590-2021