Z-1500-2023 Class II Ongoing
FDA device recall Z-1500-2023 was initiated by GE Healthcare on March 28, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2023
- Initiation Date
- March 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
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
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 Pattern
Worldwide Distribution
Code Information
No UDI/DI for these products: a) 2066908-061, Product ID Numbers: HC3062-Centricity Universal Viewer-01462397; b) 2066908-077, Product ID Numbers: YP3150-Centricity Universal Viewer-01639018; c) 2066908-086, Product ID Numbers: 100707-1-Centricity Universal Viewer-00558649, 9842-4-Centricity Universal Viewer-19386293; d) 2066908-111, Product ID Numbers: 1045-1-Centricity Universal Viewer-00558651, 1045-1-Centricity Universal Viewer-19607785; e) 2066908-123, Product ID Numbers: 4705-1-Centricity Universal Viewer-02398923; f) 2066908-136, Product ID Numbers: 4723-1-Centricity Universal Viewer-02303576, 104648-2-Centricity Universal Viewer-02354806, 101272-1-Centricity Universal Viewer-00558671, ZA2533-Centricity Universal Viewer-00116577, 280801-Centricity Universal Viewer-19737221; g) 2066908-150, Product ID Numbers: 100759-1-Centricity Universal Viewer-02360986, 100713-1-Centricity Universal Viewer-00558259, 100713-1-Centricity Universal Viewer-01982629, 100512-1-Centricity Universal Viewer-00558264, 3727-1-Centricity Universal Viewer-00558421, RU9761-UW PACS-IW UP TO 10K-02336112