GE Healthcare Medical Imaging Software Vulnerability Allows Unauthorized System Access
GE Healthcare's Centricity medical imaging software has a security vulnerability that allows service login credentials to be identified. A malicious actor could exploit this to access or manipulate patient data.
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 recall involving a medical device security vulnerability that could allow unauthorized access to sensitive patient data. The hazard is real but no incidents or patient harm have been reported, meeting the rubric for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
GE Healthcare is recalling Centricity Universal Viewer (UV) and related medical imaging and cardiology software products due to a security vulnerability in the service login credentials system. The affected products include multiple model numbers of Centricity UV, Centricity PACS-IW, Centricity Radiology RA600, and Centricity Cardiology CA1000. In total, 2,653 units are subject to this recall with worldwide distribution.
The vulnerability allows the service login credentials to be identified by unauthorized users. A malicious actor with these credentials could log into the system and potentially access or manipulate patient data stored within it.
This recall affects healthcare facilities worldwide that use any of the affected GE Healthcare Centricity product models. Any organization using these medical imaging and cardiology systems is potentially impacted.
Healthcare facilities should contact GE Healthcare for guidance on addressing this security vulnerability. GE Healthcare has classified this as a Class II recall, and users should follow any remediation instructions provided by GE Healthcare to secure their systems against unauthorized access.
The recalled product
- Product
- GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308…
- Manufacturer
- GE Healthcare
- Affected units
- 2,653
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)
- Model/Catalog/code # 2066908-077
- Installed Product ID 000346895-Centricity Universal Viewer-01804910
- UDI UDI Not Required
- System ID HCIT1584981UV
- Installed Product ID 3444574-Centricity Universal Viewer-19417270
- System ID RSMKG-SERPONG02
- Model/Catalog/code # 2066908-136
- Installed Product ID 280801-Centricity Universal Viewer-19737221
- System ID HCIT1545332UVCTRL
- Installed Product ID 651342-Centricity Universal Viewer-01365218
- System ID RSPBINTARO3
- Installed Product ID 265719-Centricity Universal Viewer-01455055
- System ID HCIT4376494UV
- Model/Catalog/code # 2066908-150
- Installed Product ID KE2701-DF UV 50K BASE-00394965
- System ID KE2701UV01
- Installed Product ID KE0301-Centricity Universal Viewer-00116859
- System ID KE0301UV01
- Installed Product ID KE4102-Centricity Universal Viewer-01402658
- System ID KE4102UW02
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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