Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling its Centricity PACS Foundation software used for storing, reading, and analyzing medical images. The software has a defect that can cause incorrect patient images to be displayed when viewing studies directly from the Enterprise Archive or VNA (Virtual Network Archive), because updated series or studies may not be present in the archive. The recall affects 92 units worldwide, including 47 in the United States distributed to Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Missouri, New Jersey, New York, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, and Washington, as well as international locations including Brazil, Canada, Chile, France, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain, and the United Kingdom. The affected software versions are CPACS 6.0 SP9, CPACS 6.0 SP9.0.1, and CPACS 6.0 SP9.0.1.5.
The recall record does not specify a remedy or action that affected consumers should take.
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: 92 (47 US 103 OUS) Lot/code info: UDI # 840682104807 Model # 2098268-001 Software Version CPACS 6.0 SP9, CPACS 6.0 SP9.0.1 and CPACS 6.0 SP9.0.1.5
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.