FDA-Device2025-11-19Class II
ProxiDiagnost N90; Model Number: 706110;
Philips Medical Systems DMC GmbH
Hazard
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Sold states
Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,
Affected count
41 units
Manufactured in
Development And Manufacturing Ctr., Rontgenstr. 24, Hamburg, Germany
Products
ProxiDiagnost N90; Model Number: 706110;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0461-2026Don't want to check this manually?
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