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FDA (Device enforcement)Recalled 2022-06-14closedclass ii

GE Healthcare, LLC: Centricity PACS Software Version 7.0 SP0.0.4.7

Is my product affected?

Centricity PACS Software Version 7.0 SP0.0.4.7

  • UPC 00840682145572

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare issued a recall for Centricity PACS Software Version 7.0 SP0.0.4.7 affecting 47 installations worldwide. The software's Event Notification Manager functionality fails to process notifications when studies are modified after they have been verified. The affected installations are located in Colorado, Nevada, Ohio, Pennsylvania, and Washington in the United States, as well as in Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and the United Kingdom.

The recall notice does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

Details from the source

Reason for recall: The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. Distribution: Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom. Quantity: 47 installations Lot/code info: Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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