Z-0139-2024 Class II Ongoing
FDA device recall Z-0139-2024 was initiated by GE Healthcare on September 14, 2023 and is designated Class II. Reason for recall: GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal View… The recall status is ongoing. Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- September 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Reason for Recall
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Distribution Pattern
US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam
Code Information
UDI/DI none, Installed Product ID #: 100707-1-Centricity Universal Viewer-00558649, 1045-1-Centricity Universal Viewer-00558651, 1045-1-Centricity Universal Viewer-19607785, 100759-1-Centricity Universal Viewer-02360986, 9842-4-Centricity Universal Viewer-19386293, 4723-1-Centricity Universal Viewer-02303576, 104648-2-Centricity Universal Viewer-02354806, 101272-1-Centricity Universal Viewer-00558671, 100713-1-Centricity Universal Viewer-00558259, 100713-1-Centricity Universal Viewer-01982629, 4705-1-Centricity Universal Viewer-02398923, 100512-1-Centricity Universal Viewer-00558264, 3727-1-Centricity Universal Viewer-00558421, HC3062-Centricity Universal Viewer-01462397, RU9761-UW PACS-IW UP TO 10K-02336112, ZA2533-Centricity Universal Viewer-00116577, YP3150-Centricity Universal Viewer-01639018