FDA-Device2020-02-26Class II
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Philips Medical Systems Gmbh, DMC
Hazard
When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
Sold states
Worldwide distribution US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NC, NJ, NY, OH, TX, UT, VA and countries of Canada, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Egypt, Ethiopia, France, Germany, Ghana, Hungary, Iran, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Nigeria, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
Affected count
116
Manufactured in
Development And Manufacturing Ctr., Rontgenstr. 24, Hamburg, Germany
Products
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2020Don't want to check this manually?
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