The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2502-2021·Announced 2021-09-29

Centricity PACS Medical Imaging System Image Acquisition and Synchronization Failures

GE Healthcare's Centricity PACS-IW system experiences image acquisition and synchronization failures that could impair the display of medical images. The software malfunction affects 392 devices globally.

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 source reports functional failures in a medical imaging system with no reported illnesses or injuries. This represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for Score 3 (High).

Plain-English summary

GE Healthcare has recalled the Centricity PACS-IW with Universal Viewer, a medical imaging system used to display and manage medical images, including mammograms, and imaging data from various sources.

The recalled system experiences image acquisition failures and synchronization failures with the Centricity Enterprise Archive. These failures affect the software version 5.0.x identified by product code 2068177-001.

The recall affects 392 devices worldwide: 219 in the United States and 173 distributed internationally. Affected U.S. states include Alaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Washington, Wisconsin, West Virginia, and Wyoming. International distribution includes Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom, and Uruguay.

The recalled product

Product
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging System / PACS
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 (16)

  • 1-121967267
  • 1-429329281
  • DGC19607785
  • HC3062UV01
  • HCIT1401012UW
  • HCIT4331279UV
  • PACS-IW-127
  • PACS-IW-219
  • PACS-IW-2770
  • PACS-IW-323
  • PACS-IW-421
  • RICHMONDU14767331
  • RICHMONDU15531177N1
  • X1347906 / X1347909
  • YP315021
  • ZA2412PAC21 and ZA2533PAC1

Distribution

Distributed in 34 states:

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 →

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