GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; S

FDA device recall Z-1475-2026 · posted 2026-02-27 · Open, Classified

Recall details

Recalling firm

GE Healthcare

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,

Action taken

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 01/16/2026 by letter delivered via traceable means. The notice explained the issue and risk, and requested the following: Actions to be taken by Customer/User: "To determine whether you have ZFP Patient Timeline configured at your site, please contact your site administrator. " If you do not have the ZFP Patient Timeline, you can continue to use Centricity Universal Viewer Zero Footprint Client (ZFP) DICOM viewer." "Review all patient studies that were reviewed using the ZFP Patient Timeline to ensure the correct images were reviewed for each patient. GE HealthCare recommends that you discontinue the use of ZFP Patient Timeline." If you do have the ZFP Patient Timeline, pending correction by GE HealthCare, please follow the instructions below: If your site requires the use of Patient Timeline, the following steps must be followed each time a different patient is loaded to ensure the proper series is displayed for this patient: 1. Change the layout to single viewport by selecting the Full view in the Layout Selector (User Manual Section 2.5.1). 2. Manually drag and drop the series from the Navigator into the viewport (User Manual Section 2.4.1). GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Device Design

Status

Open, Classified

Product code

LLZ

Quantity affected

250 units

Distribution

Worldwide distribution - US Nationwide and the countries of Belarus, Brazil, Canada, China, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Leba

Date initiated

2026-01-16

Date posted

2026-02-27

Location

Chicago, IL

Related 510(k) clearances