GE Healthcare Centricity Viewer Security Vulnerability Could Allow Unauthorized Access
GE Healthcare's Centricity Universal Viewer Zero Footprint medical imaging software contains a security vulnerability that could allow unauthorized access and patient data manipulation. Approximately 120 units are affected worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 potential security vulnerability with no reported incidents of unauthorized access or patient data compromise. Per the rubric, recalls involving theoretical risks without reported harm qualify as High (3) when they represent risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare has recalled its Centricity Universal Viewer Zero Footprint (ZFP) medical imaging software due to a potential security vulnerability. The affected product includes multiple model numbers and facility-specific installations distributed across healthcare organizations worldwide.
The vulnerability could allow a malicious actor to gain unauthorized access to the system and potentially manipulate patient data, affecting the security and integrity of medical information stored within affected installations.
Approximately 120 units have been distributed worldwide, including to healthcare facilities in the United States and in Algeria, Argentina, Brazil, China, Dominican Republic, France, Germany, India, Indonesia, Ireland, Israel, Japan, Kuwait, Malaysia, Mexico, Panama, Qatar, Russia, Saudi Arabia, Singapore, Spain, and the United Kingdom.
For more information about this recall, reference FDA recall number Z-0318-2025.
The recalled product
- Product
- GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900…
- Manufacturer
- GE Healthcare
- Affected units
- 120
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 (20)
- UDI/DI 00840682102988 for all models: 1) 2089507-083
- 103378-Centricity Universal Viewer Zero Footprint / ZFP-20039058
- 1664823-Centricity Universal Viewer Zero Footprint / ZFP-20080654
- 493356-Centricity Universal Viewer Zero Footprint / ZFP-20085691
- Medireport-Centricity Universal Viewer Zero Footprint / ZFP-02291850
- Medireport-Centricity Universal Viewer Zero Footprint / ZFP-02291877
- Medireport-Centricity Universal Viewer Zero Footprint / ZFP-02292580
- 81077-Centricity Universal Viewer Zero Footprint / ZFP-20680055
- IL1469-Centricity Universal Viewer Zero Footprint / ZFP-02156638
- JP-110145-Centricity Universal Viewer Zero Footprint / ZFP-01275393
- 1333629-Centricity Universal Viewer Zero Footprint / ZFP-01300332
- 2) 2089507-093
- 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900
- 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-02347996
- 423834-Centricity Universal Viewer Zero Footprint / ZFP-02286658
- 1407636-Centricity Universal Viewer Zero Footprint / ZFP-02304121
- 651240-Centricity Universal Viewer Zero Footprint / ZFP-02173181
- 268034-Centricity Universal Viewer Zero Footprint / ZFP-02402520
- 3) 2089507-098
- 4) 2089507-109
Distribution
Distributed nationwide across the United States.
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