FDA-Device2024-12-11Class II
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Philips North America Llc
Hazard
Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.
Sold states
Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.
Affected count
301 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0583-2025Don't want to check this manually?
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