FDA-Device2013-12-11Class II

Easy Diagnost Eleva Universal Fluoroscopic applications

Philips Medical Systems, Inc.
Hazard

The delivered application software was an outdated version to the model of equipment.

Sold states
Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
Affected count
19 devices
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Easy Diagnost Eleva Universal Fluoroscopic applications

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0431-2014

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