The Recall Desk
HighFDA (Devices)·Z-0140-2024·Announced 2023-11-01

Radiological imaging software may mix images from different patients

GE Healthcare Centricity Universal Viewer software versions 6.0 SP0-SP7.1 may combine radiological images from different patients into a single study, potentially affecting patient care and diagnosis.

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 is an FDA Class II medical device recall involving a software defect that poses a risk of patient harm through data integrity issues (mixing images from different patients). Per the rubric, with no reported injuries or illnesses, this is classified as a risk-of-harm product without reported injury, yielding a High (3) score.

Plain-English summary

GE Healthcare has issued a recall of Centricity Universal Viewer software versions 6.0 SP0 through 6.0 SP7.1, a radiological image processing system used in medical facilities. The software may inadvertently store images from two different patients within a single study, which could lead to diagnostic errors or patient harm.

The affected software is used across the United States and numerous international locations. Approximately 329 units have been distributed. The issue affects Centricity Universal Viewer V6.0 with PACS-IW foundation, as well as related Centricity PACS-IW systems.

No injuries or adverse events have been reported at this time.

The recalled product

Product
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Manufacturer
GE Healthcare
Category
Medical Device — Radiological Imaging System
Hazard
  • patient-data-mix
  • mis-diagnosis-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)

  • UDI/DI 840682103800
  • Installed Product ID #: 102123-1-Centricity Universal Viewer-00558570
  • 102123-1-Centricity Universal Viewer-02157634
  • 1011-1-Centricity Universal Viewer-00558109
  • 1011-1-Centricity Universal Viewer-02097166
  • 1011-1-Centricity Universal Viewer-02097165
  • 100666-1-Centricity Universal Viewer-14194768
  • 100666-1-Centricity Universal Viewer-20084199
  • 9789-1-Centricity Universal Viewer-00558645
  • 4413-2-Centricity Universal Viewer-02288447
  • 4267-5-Centricity Universal Viewer-19618406
  • 100763-1-Centricity Universal Viewer-00558366
  • 101171-1-Centricity Universal Viewer-02398531
  • 104535-3-Centricity Universal Viewer-02396026
  • 104535-3-Centricity Universal Viewer-02396027
  • 104535-3-Centricity Universal Viewer-02396028
  • 104535-3-Centricity Universal Viewer-02396029
  • 11438-1-Centricity Universal Viewer-00558464
  • 104535-4-Centricity Universal Viewer-02396030
  • 104535-4-Centricity Universal Viewer-01806096

Distribution

Distribution scope not specified by the agency.

Related recalls

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