FDA-Device2020-03-25Class II
OmniDiagnost Eleva System codes 708028 708027
Philips North America, LLC
Hazard
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Sold states
Nationwide domestic distribution. Foreign distribution worldwide.
Affected count
69
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
OmniDiagnost Eleva System codes 708028 708027
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2020Don't want to check this manually?
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