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Philips North America Llc recalls Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Recalled December 11, 2024 · FDA recall Z-0583-2025 · Philips North America
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. · FDA Class II
Units
301 units
Sold at
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.
Description
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.
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →