The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0226-2016·Announced 2015-11-11

GE Healthcare Recalls Centricity Universal Viewer Due to Inaccurate X-ray Measurements

GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher because magnified projection X-ray images may display inaccurate distance measurements.

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 with a defect that could lead to inaccurate clinical data (inaccurate distance measurements), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher. The recall involves 5 units of the device, which is used to display medical images, including mammograms, and data from various imaging sources. The product was distributed worldwide, including in the United States and numerous international locations.

The recall was initiated because the device may display inaccurate distance measurements when viewing magnified projection X-ray images. This issue could affect the accuracy of data presented to trained professionals, such as radiologists and physicians, who use the system for medical imaging.

Consumers and healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue. The recall number is Z-0226-2016.

The recalled product

Product
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed…
Manufacturer
GE Healthcare
Category
Medical Device — Imaging Software
Hazard

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)

  • 2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT

Distribution

Distributed nationwide across the United States.

The notice also names 26 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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