FDA-Device2025-10-01Class II
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Philips North America Llc
Hazard
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Sold states
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.
Affected count
81 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2601-2025Don't want to check this manually?
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