FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: AMX Navigate Mobile X-Ray System
- Recall number
- Z-2590-2021
- Recalling firm
- GE Healthcare, LLC
- Product
- AMX Navigate Mobile X-Ray System
- Status
- Terminated
- Initiated
- 2021-06-24
- Posted
- 2021-09-29
- Terminated
- 2023-06-14
- Reason
- An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 3 units
- Distribution
- Domestic Distribution Only
- Lot, serial or model codes
- AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK
- 510(k) numbers
- ["K210982"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28