The Recall Desk
HighFDA (Devices)·Z-1466-2022·Announced 2022-08-03

GE Centricity PACS Software fails to notify of exam study modifications

GE Healthcare's Centricity PACS software version 7.0 SP0.0.4.7 does not alert users when previously verified imaging studies are modified, potentially causing clinicians to use outdated or changed data without awareness.

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 functionality defect in a clinical imaging system. No adverse events are reported; however, the notification failure creates risk for untracked modifications to patient imaging data, which could impact clinical decision-making if end users are unaware of study changes.

Plain-English summary

Centricity PACS Software Version 7.0 SP0.0.4.7 by GE Healthcare is being recalled due to a defect in its Event Notification Manager (ENM) function. The ENM does not send notifications when modifications are made to imaging studies that have already been verified or finalized.

This defect affects approximately 47 installations worldwide. Users in the United States are located in Colorado, Nevada, Ohio, Pennsylvania, and Washington. International locations affected include Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and the United Kingdom.

When a clinician or administrator modifies a previously verified imaging study, other users who depend on that data may not be notified of the change. This could lead to clinical decisions based on outdated or altered information without proper awareness that the study was modified.

Users should contact GE Healthcare for an updated software version and implement manual verification procedures to ensure that study modifications are properly communicated to all relevant staff.

The recalled product

Product
Centricity PACS Software Version 7.0 SP0.0.4.7
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging / PACS Software
Hazard
  • notification-failure
  • software-defect
  • untracked-modifications

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 (2)

  • Model: 5831882-012
  • Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572

Distribution

Distributed nationwide across the United States.

Related recalls

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