Recalls / —

—#189073

Product

AMX Navigate Mobile X-Ray System

FDA product code

IZL — System, X-Ray, Mobile

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K210982

Affected lot / code info

AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK

Why it was recalled

An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

Domestic Distribution Only

Timeline

Recall initiated

2021-06-24

Posted by FDA

2021-09-29

Terminated

2023-06-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #189073. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.