Product Safety Recalls

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GE Healthcare, LLC Recall 90525

Description: Centricity PACS Software Version 7.0 SP0.0.4.7

GE Healthcare, LLC Recall 90525 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1466-2022
Event ID90525
Event DescriptionCentricity PACS Software Version 7.0 SP0.0.4.7
Product TypeDevices
DistributionWorldwide 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.
Quantity47 installations
Recall ReasonThe Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
Device Classification20220803
Device Code InfoModel: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
Center Classification Date20220725
Recall Initiation Date20220614
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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