GE Healthcare Recalls Centricity Universal Viewer Zero Footprint Client Due to Patient Data Mismatch

FDA Recalls high FDA · · Worldwide

GE Healthcare has initiated a voluntary recall of 250 units of its radiological image processing software due to a defect where displayed patient information may not match the images shown.

What Happened

GE Healthcare has initiated a voluntary recall of the Centricity Universal Viewer Zero Footprint Client (ZFP). The recall was prompted by a software defect where, under certain workflows, patient information shown in the viewer may not match the images actually displayed. This issue occurs on systems with Patient Timeline installed using specific software versions.

Which Products Are Affected

The recall affects 250 units of the GE Healthcare Centricity Universal Viewer Zero Footprint Client, classified as a radiological image processing system. The affected software versions are ZFP v6.0: SP11.6, SP11.6.0.1, and SP11.6.1.

Specific model numbers and UDI information include:

  • Model Numbers: 2110344-039, 2110344-046, 2110344-047
  • UDI/DI: 00840682102988
  • Recall Number: Z-1475-2026

The distribution of these units is worldwide, including the United States nationwide and over 30 other countries such as Canada, China, Germany, Japan, and the United Kingdom.

What You Should Do

GE Healthcare began notifying customers of the issue via a formal letter on January 16, 2026. Healthcare facilities and providers using the affected versions of the Centricity Universal Viewer should follow the instructions provided in the firm’s notification letter. For additional information or inquiries regarding the recall, customers may contact GE Healthcare at their Chicago office located at 500 W Monroe St, Chicago, IL 60661.

Why This Matters

This recall is critical because a mismatch between patient identification data and radiological images can lead to misdiagnosis or incorrect medical treatment, posing a significant risk to patient safety.

Source

FDA Recall Notification - Recall Number Z-1475-2026

Source: FDA Official Notice

Frequently Asked Questions

What is this fda recalls alert about?
GE Healthcare has initiated a voluntary recall of 250 units of its radiological image processing software due to a defect where displayed patient information may not match the images shown.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
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