FDA-Device2023-08-09Class II
Azurion 7 M20. X-ray Image guided Therapy System.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kenya, South Korea, Libya, Lithuania, Malaysia, Maldives, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Vietnam.
Affected count
648 units
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Azurion 7 M20. X-ray Image guided Therapy System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2284-2023Don't want to check this manually?
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