AMX Navigate Mobile X-Ray System recallZ-2590-2021 · GE Healthcare, LLC · initiated Jun 24, 2021
Class II Terminated All recalls posted in September 2021
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2590-2021
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 24, 2021
- Posted by the FDA
- Sep 29, 2021
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 3 units
- Product code
- IZL
- FDA submissions
- K210982
- Distribution
- Domestic Distribution Only
Product description
AMX Navigate Mobile X-Ray System
Code information (models, lots, serial numbers)
AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK
Other devices under the same FDA submission
1 device cleared under K210982 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AMX NavigateGE Medical Systems, L.L.C. · System, x-ray, mobile2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page