The Recall Desk
HighFDA (Devices)·Z-0139-2024·Announced 2023-11-01

Centricity PACS-IW Medical Imaging System Mixed Patient Data

Centricity PACS-IW medical imaging software versions may store images from two different patients within a single study, creating potential clinical confusion during diagnostic review.

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 with no reported injuries, illnesses, or deaths. While the data integrity issue presents a potential risk to clinical workflow and patient safety, the absence of actual harm and the Class II designation place this at severity 3 (High) per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare has identified an issue with Centricity PACS-IW and related medical imaging systems. In affected versions (Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0, and Centricity Universal Viewer V6.0 with PACS-IW foundation), images from two different patients may be stored together in a single study.

When patient images from different individuals are incorrectly grouped in the same study, medical staff reviewing the images may inadvertently see or reference data belonging to another patient. This creates a potential for clinical confusion during diagnostic review and reporting.

Seventeen units of affected imaging systems have been distributed in the United States and 27 other countries, including Canada, Germany, the United Kingdom, and others worldwide.

GE Healthcare has notified customers of this issue.

The recalled product

Product
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Manufacturer
GE Healthcare
Category
Medical Device — Medical Imaging / PACS
Hazard
  • patient-data-mixing

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 (18)

  • UDI/DI none
  • Installed Product ID #: 100707-1-Centricity Universal Viewer-00558649
  • 1045-1-Centricity Universal Viewer-00558651
  • 1045-1-Centricity Universal Viewer-19607785
  • 100759-1-Centricity Universal Viewer-02360986
  • 9842-4-Centricity Universal Viewer-19386293
  • 4723-1-Centricity Universal Viewer-02303576
  • 104648-2-Centricity Universal Viewer-02354806
  • 101272-1-Centricity Universal Viewer-00558671
  • 100713-1-Centricity Universal Viewer-00558259
  • 100713-1-Centricity Universal Viewer-01982629
  • 4705-1-Centricity Universal Viewer-02398923
  • 100512-1-Centricity Universal Viewer-00558264
  • 3727-1-Centricity Universal Viewer-00558421
  • HC3062-Centricity Universal Viewer-01462397
  • RU9761-UW PACS-IW UP TO 10K-02336112
  • ZA2533-Centricity Universal Viewer-00116577
  • YP3150-Centricity Universal Viewer-01639018

Distribution

Distribution scope not specified by the agency.

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