FDA Medical devices recall · April 9, 2025

GE Healthcare Centricity Universal Viewer (UV)… recall

Read the official FDA notice ↗

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; 13) 2088026-406; 14) 2088026-506; 15) 2088026-614; 16) 2088026-713; 17) 2088026-714; 18) 2088026-715; 19) 2088026-723; 20) 2088026-806; 21) 2088026-906; 22) 2088026-936; 23) 2088026-940; 24) 2088026-943; 25) 2088026-946; 26) 2088026-948; 27) 2088026-957; 28) 2088026-959; 29) 2088026-960; 30) 2088026-961; 31) 2088026-962; 32) 2088026-967; 33) 2088026-969; 34) 2088026-970; 35) 2088026-971; 36) 2088026-973; 37) 2088026-985; 38) 2088026-989; 39) 2088026-990; 40) 2088026-993; 41) 2088026-994; 42) 2089629-003; 43) 2100169-001; 44) 2100491-006; 45) 2100491-012; 46) 2102675-010; 47) 2102675-101; 48) 2102676-001; 49) 2104867-001; 50) 2104867-044; 51) 2104867-045; 52) 2111141-004; 53) 5826659-002; 54) 5826659-013; 55) 5826659-014; 56) 5826659-016; 57) 5826659-017; 58) 5826659-018; 59) 5826659-019; 60) 5826659-021; 61) 5826659-022; 62) 5826659-023; 63) 5826659-025; 64) 5826659-026; 65) 5826659-027; 66) 5826659-028; 67) 5826659-029; 68) 5826659-030; 69) 5826659-032; 70) 5826659-033; 71) K1220JWED; 72) K2042VJED.

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Model/Catalog/code # 2066908-077, Installed Product ID 000346895-Centricity Universal Viewer-01804910, UDI UDI Not Required, System ID HCIT1584981UV; Model/Catalog/code # 2066908-077, Installed Product ID 3444574-Centricity Universal Viewer-19417270, UDI UDI Not Required, System ID RSMKG-SERPONG02; Model/Catalog/code # 2066908-136, Installed Product ID 280801-Centricity Universal Viewer-19737221, UDI UDI Not Required, System ID HCIT1545332UVCTRL; Model/Catalog/code # 2066908-136, Installed Product ID 651342-Centricity Universal Viewer-01365218, UDI UDI Not Required, System ID RSPBINTARO3; Model/Catalog/code # 2066908-136, Installed Product ID 265719-Centricity Universal Viewer-01455055, UDI UDI Not Required, System ID HCIT4376494UV; Model/Catalog/code # 2066908-150, Installed Product ID KE2701-DF UV 50K BASE-00394965, UDI UDI Not Required, System ID KE2701UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE0301-Centricity Universal Viewer-00116859, UDI UDI Not Required, System ID KE0301UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE4102-Centricity Universal Viewer-01402658, UDI UDI Not Required, System ID KE4102UW02; Model/Catalog/code # 2066908-150, Installed Product ID KE1701-Centricity Universal Viewer-01292401, UDI UDI Not Required, System ID KE1701UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE3502-Centricity Universal Viewer-01400662, UDI UDI Not Required, System ID KE3502UW02; Model/Catalog/code # 2066908-150, Installed Produc

Distribution

Worldwide distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1483-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.