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Terminated

AMX Navigate Mobile X-Ray System

FDA Recall Z-2590-2021 · Posted 2021-09-29

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIZL
Date Initiated2021-06-24
Date Terminated2023-06-14
Product Quantity3 units

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

Domestic Distribution Only

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K210982AMX NavigateGe Medical Systems, LLC · 2021-04-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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