FDA-Device2023-05-10Class II
Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System
GE Healthcare
Hazard
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
Sold states
Worldwide Distribution
Affected count
17 units
Manufactured in
500 W Monroe St, Chicago, IL, United States
Products
Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1500-2023Don't want to check this manually?
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