FDA-Device2013-06-26Class II

Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.

Philips Healthcare Inc.
Hazard

An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used

Sold states
Worldwide Distribution - US Nationwide and the country of Canada.
Affected count
66 units
Manufactured in
3000 Minuteman Road, Andover, MA, United States
Products
Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1449-2013

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