Summary
The FDA issued a Class II for Centricity PACS Software Version 7.0 SP0.0.4.7 by GE Healthcare, LLC. Reason: The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verif.
Details
Source
Device Recall
External ID
Z-1466-2022
Action Date
2022-08-03
Status
Terminated
Category
device
Product Description
Centricity PACS Software Version 7.0 SP0.0.4.7
Lot/Code Info: Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
Quantity Affected: 47 installations
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-14
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 413 device-related FDA actions this month.
GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Healthcare, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Healthcare, LLC have FDA actions?
GE Healthcare, LLC has 104 FDA actions in our database, including 104 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1466-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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