Recall Z-1475-2026— GE Healthcare

Name: FDA recall Z-1475-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-16

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, initiated 2026-01-16. It names one FDA 510(k) clearance: K131977. Product: GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological. Reason: Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,.

Recalling firm: GE Healthcare
Classification: Class II
Status: Ongoing
Initiated: 2026-01-16
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K131977 — CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENTGE Healthcare·cleared 2013-09-17

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

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

Reason for recall

Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,

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