FDA-Device2013-06-26Class II
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Philips Healthcare Inc.
Hazard
Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment.
Sold states
Worldwide Distribution - USA Nationwide and the country of Canada
Affected count
101 units
Manufactured in
3000 Minuteman Road, Andover, MA, United States
Products
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1448-2013Don't want to check this manually?
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