FDA-Device2012-08-15Class II
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Philips Healthcare Inc.
Hazard
When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.
Sold states
Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom
Affected count
41 units
Manufactured in
3000 Minuteman Road, Andover, MA, United States
Products
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2156-2012Don't want to check this manually?
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