Z-2590-2021 Class II Terminated
FDA device recall Z-2590-2021 was initiated by GE Healthcare, LLC on June 24, 2021 and is designated Class II. Reason for recall: An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system. The recall status is terminated (terminated June 14, 2023). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- June 24, 2021
- Termination Date
- June 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
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 Pattern
Domestic Distribution Only
Code Information
AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK