FDA-Device2025-07-02Class II
Spectral CT. Computed tomography X-ray system.
Philips North America Llc
Hazard
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Sold states
Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.
Affected count
370 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Spectral CT. Computed tomography X-ray system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2034-2025Don't want to check this manually?
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