FDA-Device2020-03-25Class II
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
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
4938
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1486-2020Don't want to check this manually?
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