The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0034-2014·Announced 2013-10-30

GE Healthcare Recalls Centricity Cardio Imaging 5.0 Software

GE Healthcare is recalling Centricity Cardio Imaging 5.0 software due to a potential image labeling error in the Image Viewer that may affect diagnostic interpretation.

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: The recall involves a medical device software with a potential safety risk regarding image labeling, which could impact diagnostic interpretation. No specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare is recalling the Centricity Cardio Imaging 5.0 software, a Picture Archiving and Communication System (PACS) used to assist trained professionals in the diagnosis and treatment of cardiac and vascular disease. The recall is due to a potential safety risk in the Image Viewer software where an image labeling situation exists.

The issue occurs when multiple studies are displayed side by side, either by selecting "Compare Study" from the Study List or by opening prior studies in the Patient Folder. In these cases, the Viewer differentiates the studies with a label, but the source text indicates a potential risk associated with this labeling. The product is distributed nationwide in the United States, specifically in the state of Oklahoma.

This software is intended for use by physicians, cardiologists, radiologists, nurses, medical technicians, and assistants. It is not intended for use in the patient vicinity. Users should be aware of the potential for mislabeling when comparing studies.

The recalled product

Product
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other…
Manufacturer
GE Healthcare It
Category
Medical Device — Software
Hazard
Affected units
1

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 (1)

  • Software Version: 5.0

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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