FDA Medical Device Recalls (openFDA)
GE Healthcare: 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, 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, JP-310027-Centricity Universal Viewer Zero Footprint / ZFP-02033125; 4) 2089507-109, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095312, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095313, 327750-Centricity Universal Viewer Zero Footprint / ZFP-02184508; 5) 2089507-111, 105468-1-Centricity Universal Viewer Zero Footprint / ZFP-02254840, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-00096090, JP-340111-Centricity Universal Viewer Zero Footprint / ZFP-01275379, JP-275353-Centricity Universal Viewer Zero Footprint / ZFP-02042636; 6) 2089507-112, 3922-25-Centricity Universal Viewer Zero Footprint / ZFP-01290685, 3922-17-Centricity Universal Viewer Zero Footprint / ZFP-00098229, 1503586-Centricity Universal Viewer Zero Footprint / ZFP-21016603, RU0994-Centricity Universal Viewer Zero Footprint / ZFP-02331255; 7) 2089507-114, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-02360229, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225897, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225898, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225904, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01371500, M51725-Centricity Universal Viewer Zero Footprint / ZFP-01300873, M1781854-Centricity Universal Viewer Zero Footprint / ZFP-01553772, 609334-Centricity Universal Viewer Zero Footprint / ZFP-01282257, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-22186138, CMC-Centricity Universal Viewer Zero Footprint / ZFP-01820241, JP-100014-Centricity Universal Viewer Zero Footprint / ZFP-01890709, KW1102-Centricity Universal Viewer Zero Footprint / ZFP-02191178, 59219_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-02327073, QA1114-Centricity Universal Viewer Zero Footprint / ZFP-02306397, SAU1433-Centricity Universal Viewer Zero Footprint / ZFP-01457278, TTSH-CVIS-Centricity Universal Viewer Zero Footprint / ZFP-02041523, NE4651-Centricity Universal Viewer Zero Footprint / ZFP-00038599, NE6703-Centricity Universal Viewer Zero Footprint / ZFP-00038552, NE6731-Centricity Universal Viewer Zero Footprint / ZFP-00038461, NE3006-Centricity Universal Viewer Zero Footprint / ZFP-00038362, NE2196-Centricity Universal Viewer Zero Footprint / ZFP-00038588, NPV738-Centricity Universal Viewer Zero Footprint / ZFP-00038637, NE2031-Centricity Universal Viewer Zero Footprint / ZFP-00038578, NE7405-Centricity Universal Viewer Zero Footprint / ZFP-00038372, NE2162-Centricity Universal Viewer Zero Footprint / ZFP-00038563, NE4878-
- Recall number
- Z-0318-2025
- Recalling firm
- GE Healthcare
- 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, 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, JP-310027-Centricity Universal Viewer Zero Footprint / ZFP-02033125; 4) 2089507-109, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095312, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095313, 327750-Centricity Universal Viewer Zero Footprint / ZFP-02184508; 5) 2089507-111, 105468-1-Centricity Universal Viewer Zero Footprint / ZFP-02254840, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-00096090, JP-340111-Centricity Universal Viewer Zero Footprint / ZFP-01275379, JP-275353-Centricity Universal Viewer Zero Footprint / ZFP-02042636; 6) 2089507-112, 3922-25-Centricity Universal Viewer Zero Footprint / ZFP-01290685, 3922-17-Centricity Universal Viewer Zero Footprint / ZFP-00098229, 1503586-Centricity Universal Viewer Zero Footprint / ZFP-21016603, RU0994-Centricity Universal Viewer Zero Footprint / ZFP-02331255; 7) 2089507-114, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-02360229, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225897, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225898, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225904, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01371500, M51725-Centricity Universal Viewer Zero Footprint / ZFP-01300873, M1781854-Centricity Universal Viewer Zero Footprint / ZFP-01553772, 609334-Centricity Universal Viewer Zero Footprint / ZFP-01282257, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-22186138, CMC-Centricity Universal Viewer Zero Footprint / ZFP-01820241, JP-100014-Centricity Universal Viewer Zero Footprint / ZFP-01890709, KW1102-Centricity Universal Viewer Zero Footprint / ZFP-02191178, 59219_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-02327073, QA1114-Centricity Universal Viewer Zero Footprint / ZFP-02306397, SAU1433-Centricity Universal Viewer Zero Footprint / ZFP-01457278, TTSH-CVIS-Centricity Universal Viewer Zero Footprint / ZFP-02041523, NE4651-Centricity Universal Viewer Zero Footprint / ZFP-00038599, NE6703-Centricity Universal Viewer Zero Footprint / ZFP-00038552, NE6731-Centricity Universal Viewer Zero Footprint / ZFP-00038461, NE3006-Centricity Universal Viewer Zero Footprint / ZFP-00038362, NE2196-Centricity Universal Viewer Zero Footprint / ZFP-00038588, NPV738-Centricity Universal Viewer Zero Footprint / ZFP-00038637, NE2031-Centricity Universal Viewer Zero Footprint / ZFP-00038578, NE7405-Centricity Universal Viewer Zero Footprint / ZFP-00038372, NE2162-Centricity Universal Viewer Zero Footprint / ZFP-00038563, NE4878-
- Status
- Open, Classified
- Initiated
- 2024-10-03
- Posted
- 2024-11-07
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- 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.
- Quantity
- 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, Malaysia, Mexico, Panama, Qatar, Russia, Saudi Arabia, Singapore, Spain, United Kingdom.
- Lot, serial or model codes
- UDI/DI 00840682102988 for all models: 1) 2089507-083, Installed Product ID Numbers: GDZH-JINWAN-Centricity Universal Viewer Zero Footprint / ZFP-02171477, 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, Installed Product ID Numbers: 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 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, Installed Product ID Numbers: JP-310027-Centricity Universal Viewer Zero Footprint / ZFP-02033125; 4) 2089507-109, Installed Product ID Numbers: 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095312, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095313, 327750-Centricity Universal Viewer Zero Footprint / ZFP-02184508; 5) 2089507-111, Installed Product ID Numbers: 6) 2089507-112, Installed Product ID Numbers: 7) 2089507-114, Installed Product ID Numbers: 8) 2089507-115, Installed Product ID Numbers: 9) 2089507-116, Installed Product ID Numbers: 10) 2089507-117, Installed Product ID Numbers: 11) 2089507-118, Installed Product ID Numbers: 12) 2089507-119, Installed Product ID Numbers:
- 510(k) numbers
- ["K131977"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3004526608
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28