FDA-Device2013-06-26Class II

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

Philips Healthcare Inc.
Hazard

An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment

Sold states
Worldwide Distribution - US Nationwide and the country of Canada.
Affected count
116 units
Manufactured in
3000 Minuteman Road, Andover, MA, United States
Products
Philips BuckyDiagnost Radiographic. 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-1450-2013

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