FDA-Device2020-03-25Class II
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
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
534
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1489-2020Don't want to check this manually?
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