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GE Healthcare Recall 93099

Description: Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System

GE Healthcare Recall 93099 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0139-2024
Event ID93099
Event DescriptionCentricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Product TypeDevices
DistributionUS 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
Quantity17 units
Recall ReasonGE 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.
Device Classification20231101
Device Code InfoUDI/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
Center Classification Date20231020
Recall Initiation Date20230914
Recalling FirmGE Healthcare
Initial Notification Letter
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