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 IATDs (Installation Acceptance Test could not be located or different templates have been used

Sold states
Worldwide Distribution - USA Nationwide and the country of Canada
Affected count
177 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-1447-2013

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