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Philips North America Llc recalls The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross
Recalled December 27, 2023 · FDA recall Z-0576-2024 · Philips North America
Hazard
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. · FDA Class II
Units
330 units
Sold at
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, Latvia, Lebanon, Moldova, Morocco, Netherlands, Palestine, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russian Federation, Saint Lucia, Saint Pierre and Miquelon, Sint Maarten , South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Viet Nam.
Description
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.
Product
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 accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →