GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 20895
FDA device recall Z-0318-2025 · posted 2024-11-07 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access the system and potentially manipulate patient data.
- Action taken
- GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to it consignees on 10/03/2024 via letter issued through a traceable means. The notice explained the issue and provided the following actions be to be implemented until the devices can be corrected: Option 1: Restrict access to these systems from the internet. or Option 2: Implement additional safeguards such as a VPN. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or a local Service Representative. GE HealthCare will correct all affected products at no cost. A GE HealthCare representative will make contact to arrange for the correction.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 120 units
- Distribution
- Worldwide distribution - United States Nationwide and the countries of Algeria, Argentina, Brazil, China, Dominican Republic, France, Germany, India, Indonesia, Ireland, Israel, Japan, Kuwait, Malaysi
- Date initiated
- 2024-10-03
- Date posted
- 2024-11-07
- Location
- Chicago, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT (K131977) | GE Healthcare | 2013-09-17 |