GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086;
Summary
The FDA issued a Class II for GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers by GE Healthcare. Reason: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & C.
Details
Source
Device Recall
External ID
Z-1487-2025
Action Date
2025-04-09
Status
Ongoing
Category
device
Product Description
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
Lot/Code Info: Model/catalog/code # 2049587-015, Installed Product ID 100707-1-Centricity Universal Viewer-00558649, UDI UDI Not Required, System ID PACS-IW-126; Model/catalog/code # 2066908-086, Installed Product ID 9842-4-Centricity Universal Viewer-19386293, UDI UDI Not Required, System ID GA001PACTRL01; Model/catalog/code # 2066908-136, Installed Product ID ZA2533-Centricity Universal Viewer-00116577, UDI UDI Not Required, System ID ZA2533PAC1; Model/catalog/code # 2104867-045, Installed Product ID X9003062 - HC3062-Centricity Universal Viewer-01462397, UDI (01)00840682103800(10)6.0SP50412094097001D, System ID HC3062UV01.
Quantity Affected: 4 units
Reason for Recall
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-19
Company
Chicago, IL
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 182 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Healthcare has 32 FDA actions in our database, including 18 recalls and 9 clearances.
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) 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 have FDA actions?
GE Healthcare has 32 FDA actions in our database, including 18 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1487-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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