Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Check against the official notice below — it lists the full affected range.
GE Healthcare's Centricity Universal Viewer 6.0, a software system that displays medical images and data from various imaging sources and healthcare information systems, has been recalled due to a software defect. The defect creates a possibility that users may view incorrect patient images when accessing studies directly from the Enterprise Archive or VNA (Vendor Neutral Archive) because updated series or studies may not be present in the archive. The affected software versions include multiple iterations of version 6.0, and the recall impacts approximately 145 devices that were distributed worldwide, including to 15 U.S. states and 13 other countries.
The recall affects devices with UDI number 840682103800 and model number 2098249-002. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
Reason for recall: There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive. Distribution: Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom. Quantity: 145 (87 US 103 OUS) Lot/code info: UDI # 840682103800 Model # 2098249-002 Software Version: 6.0.9, 6.0SP9.01, CPACS 6.0 SP9.0.1, UV 6.0 SP9.0.1, UV 6.0 SP9.01.1, UV 6.0 SP9.0.1.2, UV 6.0 SP9.01.3, UV6.0 SP9.01.4, UV 6.0 SP9.01.5, UV 6.0 SP9.0.1.6, UV Version 6.0 SP5.0.4.1, UV Version 6.0 SP9, UV Version 6.0 SP9.0.0.1, UV Version 6.0 SP901, UV Version 6.0 SP9011, and UV Version 6.0 SP902
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.