The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0225-2016·Announced 2015-11-11

GE Healthcare Recalls Centricity PACS-IW Due to Inaccurate X-Ray Measurements

GE Healthcare is recalling Centricity PACS-IW software because it may display inaccurate distance measurements for magnified projection X-ray images.

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 inaccurate measurements could impact patient care, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare is recalling Centricity PACS-IW with Universal Viewer, a medical device used to display medical images and data from various imaging sources. The recall affects Versions 5.0 SP2 and higher, with 1,052 units 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 system is typically used by trained professionals, including radiologists, physicians, nurses, and medical technicians, to view, communicate, process, and display images within the system or across computer networks.

Users of the affected software should contact GE Healthcare for further instructions regarding the recall and potential corrective actions.

The recalled product

Product
The Centricity PACS-IW with Universal Viewer 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)

  • 2067131-001DVD UNIVERSAL VIEWER 5.0 - 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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