FDA-Device2013-03-13Class II
Philips Digital Diagnost Stationary radiographic system
Philips Healthcare Inc.
Hazard
When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK.
Affected count
360
Manufactured in
3000 Minuteman Road, N/A, Andover, MA, United States
Products
Philips Digital Diagnost Stationary radiographic system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0900-2013Don't want to check this manually?
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