Recall Z-1046-2025— GE Medical Systems, LLC

Name: FDA recall Z-1046-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-28

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-01-28. It names one FDA 510(k) clearance: K173612. Product: Optima XR646 HD. X-Ray imaging system.. Reason: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-01-28
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K173612 — Optima XR646 HDGe Hualun Medical Systems Co. , Ltd.·cleared 2017-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Optima XR646 HD. X-Ray imaging system.

Reason for recall

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

Data sourced from openFDA. This site is unofficial and independent of the FDA.