GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
Reason for recall: GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. Distribution: Worldwide Distribution Quantity: 329 units Lot/code info: a) 2088026-003, No UDI/DI, Product ID numbers: 233637-Centricity Universal Viewer-15773152; b) 2088026-026, No UDI/DI, Product ID numbers: 4446-2-Centricity Universal Viewer-00558643, 4491-1-Centricity Universal Viewer-00558690, 100256-3-Centricity Universal Viewer-00558700, 100256-3-Centricity Universal Viewer-01810788, 102143-1-Centricity Universal Viewer-00558685, 101044-1-Centricity Universal Viewer-00558694, 13356-2-Centricity Universal Viewer-00558681, 102335-1-Centricity Universal Viewer-00558675, 13228-1-Centricity Universal Viewer-00558678, 101274-1-Centricity Universal Viewer-00558679, 101274-1-Centricity Universal Viewer-20279342, 13125-1-Centricity Universal Viewer-02268546, 102359-1-Centricity Universal Viewer-00558696, 4578-1-Centricity Universal Viewer-00558340, A54120-Centricity Universal Viewer-00040449, KW0000-Centricity Universal Viewer-01416913, BON01-Centricity Universal Viewer-00044131, PL3277-Centricity Universal Viewer-00038831; c) 2088026-032, No UDI/DI, Product ID numbers: 1027-1-Centricity Universal Viewer-00558706, 1027-1-Centricity Universal Viewer-20759776, 124774-Centricity Universal Viewer-00000208; d) 2088026-043, No UDI/DI, Product ID numbers: 4441-1-Centricity Universal Viewer-00558677, PL3349-Centricity Universal Viewer-00038811, RU3866-Centricity Universal Viewer-01445731, RU8945-Centricity Universal Viewer-01445740, RU2580-Centricity Universal Viewer-01445743, RU7175-Centricity Universal Viewer-01445748, RU1646-Centricity Universal Viewer
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Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.