AMX Navigate Mobile X-Ray System

Date

Oct. 6, 2021

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

AMX Navigate Mobile X-Ray System

Reason

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

Distribution pattern

Domestic Distribution Only

Quantity

3 units

Codes and lots

AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK

Recall started

June 24, 2021

Device type

System, X-Ray, Mobile

Root cause (FDA)

Process control

What the company told customers

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 number

Z-2590-2021

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2590-2021. The agency record governs; check it and the company before acting.