FDA-Device2024-01-24Class II
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Philips North America Llc
Hazard
Multiple software issues that affect device functionality.
Sold states
Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Panama, Palestine, Portugal, South Korea, Spain, Switzerland, Thailand, United Kingdom.
Affected count
197 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0725-2024Don't want to check this manually?
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