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.
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: 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 Quantity: 149 units Lot/code info: UDI/DI none, Installed Product ID #: 101792-1-Centricity PACS-IW-00558370, 4345-1-Centricity PACS-IW-00558548, 12830-1-Centricity PACS-IW-00558312, 4378-1-Centricity PACS-IW-00558498, 100663-1-Centricity PACS-IW-00558514, 100858-1-Centricity PACS-IW-00558426, 100702-1-Centricity PACS-IW-00558539, 4109-1-Centricity PACS-IW-00558389, 101625-1-Centricity PACS-IW-00558531, 4593-1-Centricity PACS-IW-00558488, 100009-1-Centricity PACS-IW-00558560, 100838-1-Centricity PACS-IW-00558532, 4300-1-Centricity PACS-IW-00558207, 4294-1-Centricity PACS-IW-00558379, 13039-1-Centricity PACS-IW-00558385, 13102-1-Centricity PACS-IW-00558512, 4694-1-Centricity PACS-IW-00558556, 101742-1-Centricity PACS-IW-00558470, 101883-1-Centricity PACS-IW-00558487, 9791-1-Centricity PACS-IW-00558418, 11764-1-Centricity PACS-IW-00558388, 101689-1-Centricity PACS-IW-00558326, 4744-1-Centricity PACS-IW-00558373, 4358-1-Centricity PACS-IW-00558564, 1402-7-Centricity PACS-IW-18957305, 1402-7-Centricity PACS-IW-19265438, 1402-7-Centricity PACS-IW-18166109, 1402-7-Centricity PACS-IW-18166110, 1402-2-Centricity PACS-IW-18984905, 1402-2-Centricity PACS-IW-18985934, 1402-2-Centricity PACS-IW-19031647, 1402-1-Centricity PACS-IW-17192703, 1402-1-Centricity PACS-IW-17192704, 1402-1-Centricity PACS-IW-00558291, 13095-1-Centricity PACS-IW-00558534, 4326-4-Centricity PACS-IW-00558105, 4352-1-Centricity PACS-IW-00558316, 4443-1-Centricity PACS-IW-00558167, 4374-1-Centricity PACS-IW-00558422, 4301-1-Centricity PACS-IW-00558525
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.