The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0142-2024·Announced 2023-11-01

Radiological imaging system may display wrong patient information in workflow

GE Healthcare's Centricity Universal Viewer Workflow Manager may display exam information for a different patient when third-party reporting applications launch exams. The mismatch could lead to incorrect patient identification.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device with a risk-of-harm hazard (incorrect patient data display) that could impact patient safety in a clinical radiology setting. No illnesses or injuries have been reported, so the score does not exceed 3 per the rubric criterion for theoretical hazards without reported incidents.

Plain-English summary

GE Healthcare has recalled the Centricity Universal Viewer Workflow Manager, an image processing radiological system used in medical facilities. The system is affected by a software logic issue where certain third-party reporting applications can trigger the display of exam information on a different patient than the one the user intended to view in the Workflow Manager and Viewer.

85 units of the affected software versions (7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0) have been distributed nationwide across multiple states and internationally to Austria, Canada, France, Germany, Hong Kong, Israel, Italy, Philippines, Singapore, Thailand, Turkey, and Vietnam.

Healthcare facilities using this system should immediately verify patient identity information through secondary means before relying on the displayed patient data for clinical decisions. Contact GE Healthcare for guidance on corrected software versions or interim mitigations. Do not assume that exam information displayed in the Workflow Manager corresponds to the correct patient when using third-party reporting applications.

The recalled product

Product
Centricity Universal Viewer Workflow Manager, Image processing radiological system
Manufacturer
GE Healthcare
Category
Medical Device — Medical Imaging / Radiology
Hazard
Affected units
85

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • UDI/DI 00840682145794
  • Software versions 7.0 SP1.1
  • 7.0 SP1
  • 7.0 SP0.0.5
  • 7.0 SP0.1.0. All product IDs with an affected software version are impacted.

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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