Agency classClass IIOur severity:High FDA (Devices)·Z-1910-2019·Announced 2019-07-10

GE Healthcare Recalls Centricity Universal Viewer 6.0 Software

GE Healthcare is recalling Centricity Universal Viewer 6.0 software due to a risk of displaying incorrect patient images from archives.

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 risk-of-harm product (medical imaging software) where incorrect patient data could lead to misdiagnosis or treatment errors, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling Centricity Universal Viewer 6.0, a medical device software used to display medical images and data from various imaging sources. The recall involves 145 units distributed worldwide, including 87 units in the United States and 103 units outside the US.

The recall is issued because there is a possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images. This occurs when the updated series or study is not present in the archive, potentially leading to the display of data that does not match the intended patient.

The affected software versions include 6.0.9, 6.0SP9.01, and various other specific service pack versions listed in the recall documentation. The product was distributed to healthcare facilities in multiple US states and countries including Brazil, Canada, and the United Kingdom. Healthcare providers should verify the software version and consult the recall notice for specific corrective actions.

The recalled product

Product: Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Medical Imaging Software
Hazard: incorrect-patient-data

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 (16)

UDI # 840682103800 Model # 2098249-002 Software Version: 6.0.9
6.0SP9.01
CPACS 6.0 SP9.0.1
UV 6.0 SP9.0.1
UV 6.0 SP9.01.1
UV 6.0 SP9.0.1.2
UV 6.0 SP9.01.3
UV6.0 SP9.01.4
UV 6.0 SP9.01.5
UV 6.0 SP9.0.1.6
UV Version 6.0 SP5.0.4.1
UV Version 6.0 SP9
UV Version 6.0 SP9.0.0.1
UV Version 6.0 SP901
UV Version 6.0 SP9011
and UV Version 6.0 SP902

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, LLC 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 →

Same manufacturer · GE Healthcare, LLC

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