FDA-Device2024-02-14Class II
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
PHILIPS MEDICAL SYSTEMS
Hazard
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Sold states
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.
Affected count
US: 33, OUS 177
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1055-2024Don't want to check this manually?
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