FDA-Device2012-09-26Class II

Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

Philips Healthcare Inc.
Hazard

Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.

Sold states
Worldwide Distribution - USA including OH and WA and the country of Canada
Affected count
4 systems
Manufactured in
3000 Minuteman Road, Andover, MA, United States
Products
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2384-2012

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