Z-2590-2021Class II

AMX Navigate Mobile X-Ray System

Name: Z-2590-2021 AMX Navigate Mobile X-Ray System
Creator: GE Healthcare, LLC
Published: 2021-06-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-06-24 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of AMX Navigate Mobile X-Ray System on 2021-06-24. FDA classified it as Class II and gives the reason as "An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2590-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-24
Posted: 2021-09-29
Terminated: 2023-06-14
Recalling firm: GE Healthcare
Product: AMX Navigate Mobile X-Ray System
Product code: IZL System, X-Ray, Mobile
Reason for recall: An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
Root cause tag: manufacturing process
FDA 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 in commerce: 3 units
Distribution: Domestic Distribution Only
Product codes and lots: AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2590-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2590-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-29

Product code IZL

K210982Class IIAMX NavigateGe Medical Systems, LLC / cleared 2021-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)