FDA-Device2020-03-25Class II
Integris Allura 9, system codes 722018 722021
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
20
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Integris Allura 9, system codes 722018 722021
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2020Don't want to check this manually?
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