The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and
Check against the official notice below — it lists the full affected range.
Philips North America is recalling approximately 330 whole-body CT x-ray systems due to three software issues. These issues can cause incorrect image display, errors in interpreting patient images during reporting, and patient exposure to incorrect images or functions during clinical use. The affected systems have system codes 728143 and 728144, and were distributed to multiple states across the United States as well as numerous countries internationally.
The recall record 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.
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
Reason for recall: Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use. Distribution: Domestic: AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ, NM, NY, OH, OK, PA, RI, TN, TX; Foreign: Albania, Argentina, Australia, Austria, Bolivia, Bosnia-Herzegovina , Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kenya, Kosovo, Lao People's Democratic Republic, Quantity: 330 units Lot/code info: System Code: 728143 and 728144; UDI: (01)00884838105508(21)34035, (01)00884838105508(21)34029, (01)00884838105508(21)34030, (01)00884838105508(21)550007, (01)00884838105508(21)550009, (01)00884838105508(21)550068, (01)00884838105508(21)550012, (01)00884838105508(21)550044, (01)00884838105508(21)550049, (01)00884838105508(21)34021, (01)00884838105508(21)34076, (01)00884838105508(21)34094, (01)00884838105508(21)500519, (01)00884838105508(21)550024, (01)00884838105508(21)550048, (01)00884838105508(21)550062, (01)00884838105508(21)550003, (01)00884838105508(21)34063, (01)00884838105508(21)550027, (01)00884838105508(21)550029, (01)00884838105508(21)552006, (01)00884838105508(21)552007, (01)00884838105508(21)552009, (01)00884838105508(21)500502, (01)00884838105508(21)550020, (01)00884838085015(21)500367, (01)00884838085015(21)500379, (01)00884838085015(21)500521, (01)00884838085015(21)500138, (01)00884838085015(21)500308, (01)00884838105508(21)34074, (01)00884838105508(21)34102, (01)00884838105508(21)34053, (01)00884838105508(21)34092, (01)00884838105508(21)34008, (01)00884838105508(21)550026, (01)00884838105508(21)34028, (01)00884838105508(21)34039, (01)00884838105508(21)34048, (01)00884838105508(21)34069, (01)00884838085015(21)500110, (01)00884838085015(21)500111, (01)00884838105508(21)34041, (01)00884838105508(21)34036, (01)00884838105508(21)34065, (01)00884838105508(21)34061, (01)00884838085015(21)500433, (01)00884838105508(21)500517, (01)00884838105508(21)550060, (01)008848381
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.