FDA-Device2017-06-21Class II

Philips DigitalDiagnost 3.1.x X-Ray System

Philips Electronics North America Corporation
Hazard

During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.

Sold states
USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
Affected count
US - 132
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips DigitalDiagnost 3.1.x X-Ray System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2154-2017

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