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PHILIPS MEDICAL SYSTEMS recalls Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
Recalled February 14, 2024 · FDA recall Z-1055-2024 · PHILIPS MEDICAL SYSTEMS
Hazard
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. · FDA Class II
Units
US: 33, OUS 177
Sold at
Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.
Description
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Product
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
Manufacturer(s)
PHILIPS MEDICAL SYSTEMS
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →