FDA-Device2013-02-13Class II

Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

Philips Healthcare Inc.
Hazard

The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.

Sold states
US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.
Affected count
14 units
Manufactured in
3000 Minuteman Road, N/A, Andover, MA, United States
Products
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2013

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