The Recall Desk
HighFDA (Devices)·Z-2503-2021·Announced 2021-09-29

GE Healthcare Medical Imaging Software Recall: Image Acquisition and Archive Synchronization Failures

GE Healthcare is recalling Centricity Universal Viewer and Viewer 6.0 software due to image acquisition and synchronization failures with the Centricity Enterprise Archive that could impact diagnostic data integrity.

What this means for you

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: This FDA Class II recall involves functional failures in medical imaging software that could affect diagnostic data integrity. No injuries or illnesses have been reported, making this a risk-of-harm product where actual patient impact has not yet been documented.

Plain-English summary

GE Healthcare is recalling Centricity Universal Viewer and Viewer 6.0, medical imaging software used to display medical images and data from various imaging sources. The recall affects approximately 462 units, including 279 in the United States and 183 internationally distributed across multiple states and countries.

The software can experience image acquisition failures and synchronization failures with the Centricity Enterprise Archive. These functional failures could impact the proper operation of the imaging display and data archival system.

Affected healthcare facilities using the involved model numbers should contact GE Healthcare for guidance on remediation.

The recalled product

Product
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Nu
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Software
Hazard
  • image-acquisition-failure
  • synchronization-failure
  • data-integrity-risk

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 (20)

  • PMIO20084199
  • PACS-IW-231
  • CITRUSVAL20884363
  • CITRUSVAL20884364
  • CITRUSVAL20884365
  • PACS-IW-155
  • PRIMEHEAL02315681
  • PRIMEHEAL20501355
  • PARKVIEWC21200827 (840682103800)
  • PARKVIEWC21200830 (840682103800)
  • PACS-IWUVN2-441
  • QUEEN19630914
  • QUEEN19630915
  • QUEEN19630916T
  • QUEEN20553950
  • 203268UVSW
  • DELAWAREC01589220
  • PACS-IW-462UV
  • PACS-IW-462UVN1
  • PACS-IW-126

Distribution

Distributed in 34 states:

  • AK
  • AZ
  • CA
  • CO
  • DE
  • FL
  • GA
  • IA
  • IN
  • LA
  • MA
  • MD
  • MI
  • MN
  • MO
  • MS
  • MT
  • NC
  • ND
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • SD
  • TX
  • UT
  • WA
  • WI
  • WV
  • WY

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